Sunday, May 27, 2007

Pfizer received Food and Drug Administration approval of its Zoloft for acute and long-term treatment of social anxiety disorder last month - Branded

Pfizer received Food and Drug Administration approval of its Zoloft for acute and long-term treatment of social anxiety disorder last month. Within a day of that announcement, Wyeth released that its Effexor likewise was approved for the treatment of social anxiety disorder. These are new indications for the anti-depression drugs.

For the nine months ended Sept. 30, Wyeth reported worldwide Effexor sales of $409.3 million. Sales of Pfizer's Zoloft reached $2.2 billion in full-year 2002.

COPYRIGHT 2003 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2003 Gale Group

New recommendations for fibromyalgia relief: heated pool therapy, certain medications among new treatments

Often misunderstood and/or incorrectly diagnosed, fibromyalgia is an arthritis-related condition marked by generalized muscular pain and fatigue. Its symptoms are common and laboratory tests are generally normal, so people with fibromyalgia may be told that the condition is "all in their head." But according to the Arthritis Foundation in Atlanta, GA, about two percent of the U.S. population, or about 6 million people, may have this mysterious condition. Researchers speculate that many factors may play a role in this condition, including infection, physical trauma, emotional trauma or hormonal changes, but there is no definitive answer.

SIGNS & SYMPTOMS. Doctors generally diagnose fibromyalgia if a person has a history of widespread pain on both sides of the body and above and below the waist that has lasted for at least three months. People with fibromyalgia often have pain in at least 11 of 18 tender points--specific spots on the body which are unusually sensitive to touch. There are no specific laboratory tests available for diagnosing fibromyalgia, so doctors must rely on patient histories, self-reported symptoms, a physical examination and a manual tender point examination. As a result, it takes an average of five years for a fibromyalgia patient to get an accurate diagnosis.

NEW TREATMENTS MAY OFFER RELIEF. Once diagnosed, treatment, too, is a work-in progress. Treatment options include pain-relieving medications and medications to improve sleep, exercise programs that stretch muscles, relaxation techniques to ease muscle tension and anxiety, and educational programs.

Recently, a new assessment of fibromyalgia treatments presented at the European league Against Rheumatism (EULAR) meeting in Amsterdam added heated pool therapy combined with exercise, as well as some specific analgesics and antidepressants to the mix. In fact, substantial evidence suggests that an individually tailored exercise program in combination with heated pool therapy is especially effective and helpful for people with this painful condition, reported Ernest H. Choy, MD, FRCP, a consultant senior lecturer in rheumatology at Kings College in London, UK.

DRUG THERAPY ALSO OFFERS RELIEF. The mild narcotic tramadol (Ultram) is also helpful, he said, but he pointed out that questions regarding its long-term use remain. A number of antidepressants have also been shown to be effective in reducing pain symptoms in randomized controlled trials including amitriptyline, fluoxetine (Prozac), duloxetine (Cymbalta, Xeristar, Yentreve), and ixel (Milnacipran). Many people with fibromyalgia also have problems sleeping, and antidepressants help relieve pain and improve sleep. They are usually prescribed in lower doses than for depression. Cognitive behavioral therapy, relaxation, physiotherapy, and psychological support may also help, according to the recommendations which will be submitted for publication in the Annals of the Rheumatic Diseases.

NEEDLING AWAY AT FIBROMYALGIA? Acupuncture may also reduce symptoms, according to a study by researchers from the Mayo Clinic in Rochester, MN that appears in a recent issue of the Mayo Clinic Proceedings. In the new study of 50 people with fibromyalgia, those who received acupuncture showed significant improvements--particularly in anxiety and fatigue--compared with the control group which did not get acupuncture. The benefit produced by acupuncture was actually similar to that reported with drugs, including antidepressants, the researchers report. All participants received treatment every two to four days over a period of three weeks for a total of six sessions.

True acupuncture reduced scores on a standard measure assessing fibromyalgia-related pain by seven points, with the largest difference in scores occurring at one month. People who received acupuncture did not, however, report an increased level of activity or physical functioning, but study authors point out that this was not a predesigned endpoint; nor did they encourage participants to change behaviors.

WHAT YOU CAN DO

To relieve symptoms of fibromyalgia, consider:

* An individually tailored exercise program combined with heated pool therapy

* Taking the mild narcotic tramadol, or antidepressants

* Cognitive behavioral therapy

* Relaxation techniques

* Physiotherapy

* Psychological support

FAST FACTS

* Fibromyalgia is an arthritis-related condition marked by generalized muscular pain and fatigue.

* About two percent of the U.S. population, or about 6 million people, may have this mysterious condition.

* Researchers speculate that many factors play a role in causing fibromyalgia, including infection, physical trauma, emotional trauma or hormonal changes.

DOCTOR'S PERSPECTIVE

Daniel J. Clauw, Chronic Pain and Fatigue Research Center, Professor, Internal Medicine-Rheumatology, University of Michigan, Ann Arbor, MI

"Treatments for fibromyalgia are available and they do work for most people. If the average practicing physician used the therapies shown to be effective in fibromyalgia, the majority of patients would have their pain reasonably well-managed. Unfortunately, many physicians don't differentiate between the pain of fibromyalgia and that of arthritis and other conditions. We know that different types of pain need different types of treatment. The new EULAR recommendations may help doctors better address pain in fibromyalgia. In the new recommendations, warm water therapy just happened to have shown impressive and significant effects, but this doesn't mean that warm water therapy is what all fibromyalgia patients need. It is one way of exercising. The message is that however patients with fibromyalgia can increase their activity and/or exercise, it will improve their condition. At the end of the day, if their pain is not getting better it might be time to try other treatments."

COPYRIGHT 2006 Belvoir Media Group, LLC
COPYRIGHT 2007 Gale Group

Pfizer and Ranbaxy Laboratories went to court last month over the industry's No. 1 pharmaceutical Lipitor

Generics News--Pfizer and Ranbaxy Laboratories went to court last month over the industry's No. 1 pharmaceutical Lipitor. Ranbaxy is the first to challenge two of Pfizer's Lipitor patents, which are supposed to protect the statin from generic competition until at least 2009.

Ranbaxy's chances of prevailing in this case are slim, many analysts are saying, but the potential upside for Ranbaxy is tremendous. Lipitor generated $7.4 billion in U.S. sales for the 12 months ending September, according to IMS Health data.

COPYRIGHT 2004 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2005 Gale Group

Antiviral drug may limit herpes spread

In people who have had at least one outbreak of blistering from genital herpes, the drug famciclovir sharply reduces virus shedding from the external portions of the genitalia, a new study finds. Such shedding can spread the virus between people.

Despite the apparent risk of herpes spreading during an outbreak, most new cases of genital herpes are caused by sexual contact with an infected person without visible blisters, says Peter Leone, a physician at the University of North Carolina School of Medicine in Chapel Hill. Because such silent transmission "is what drives the epidemic," he says, inhibiting shedding could prove valuable.

Famciclovir (Famvir) is a daily antiviral pill prescribed to limit herpes outbreaks. To test whether it can also stop viral shedding, researchers identified 129 men and women with genital herpes and randomly assigned half to take famciclovir and half to get an inert pill. After 42 days, the regimens were reversed. Participants and researchers didn't know which pill a volunteer was getting.

Every day throughout the study, each participant collected swabs of his or her genital area.

Although previous tests had shown that all the participants carried the genital herpes virus, some had never had an outbreak. Analysis of the swabs revealed that those asymptomatic people were as likely to shed the virus when they were getting the drug as when they received the placebo.

In contrast, famciclovir showed an effect in participants with histories of genital herpes outbreaks. This group was only about one-fourth as likely to shed virus while getting the drug as they were while getting the placebo, says Leone, who presented the findings last month at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco.

COPYRIGHT 2006 Science Service, Inc.
COPYRIGHT 2006 Gale Group

Long-term results of taking Fosamax

Though Fosamax, the drug that is widely advertised to women, has been on the market for eight years, there are several lingering questions. How long can women safely take this drug? If Fosamax is stopped, will its bone protection benefits disappear? Should it be prescribed to middle-aged women with minimal bone loss?

The most serious concern was raised by some researchers who worry that many years of using Fosamax (or another drug like Actonel in a class called bisphosphonates) could eventually cause more fractures. Bones are constantly being remodeled, breaking down old bone and growing newer healthier bone. Bisphosphonates, however, slows this turnover, which could become counterproductive. By stopping the resorption of the old bone, the drug could prevent its replacement by new bone, thus making the bone more brittle and prone to fracture. With so many unknowns, the more cautious doctors do not prescribe bisphosphonates to women in their 50s. Until there is proof that these drugs are effective at preventing a hip fracture 20 years in the future, this seems like a safe decision because hip fractures are not likely to occur before the age of 70.

Last month, some of the information gaps surrounding Fosamax use were filled in by a pooled analysis of two clinical trials. It was entitled "Ten Years' Experience with Alendronate [Fosamax] in Postmenopausal Women" (New England Journal of Medicine, 3/18/04). Together, the trials involved nearly 1,000 women with osteoporosis, one-third of whom had spinal fractures before entering the studies. They had been randomly assigned to take either Fosamax or a placebo, and the average age at enrollment was 63. The research team led by Henry G. Bone, MD, concluded, "The therapeutic effects of alendronate [Fosamax] were sustained and well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects."

But most women take Fosamax to avoid a hip fracture, which has the most serious complications. Unfortunately, the new analysis did not address this issue. Thousands more study participants would have been needed to prove fracture prevention, wrote Dr. Bone in a letter to the New York Times.

COPYRIGHT 2004 Center for Medical Consumers, Inc.
COPYRIGHT 2004 Gale Group

Branded News - approval gained for Singulair for hay fever relief in adults and children

The FDA also approved this month Merck's Singulair for the relief of symptoms of hay fever in adults and children as young as 2 years of age.

Unlike antihistamines, Singulair treats seasonal allergies by blocking leukotrienes, substances produced by certain cells in the human body, instead of blocking histamine. Leukotrienes trigger a number of effects that have been connected with symptoms of both asthma and allergic rhinitis.

Singulair is available in tablet form for adults (10 mg) and as a cherry chewable tablet (4 mg or 5 mg) for children ages 2 to 14. Singulair also is approved to help control asthma.

COPYRIGHT 2003 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2003 Gale Group

Is lansoprazole or omeprazole more effective in treating erosive esophagitis?

Richter JE, Kahrilas PJ, Sontag SJ, et al. Comparing lansoprazole and omeprazole in onset of heartburn relief: results of a randomized, controlled trial in eta)sire esophagitis patients. Am J Gastroenterol 2001; 96:3089-98.

* BACKGROUND While the superiority of proton pump inhibitors (PPIs) over histamine-2 receptor antagonists in symptom control of gastroesophageal reflux disease (GERD) has been well established, limited work has been done comparing the efficacy of different PPIs. Theoretically, differences in pharmacokinetic properties, such as increased bioavailability of lansoprazole, could play a role in efficacy of symptom control. The purpose of this study was to demonstrate a difference between PPIs in GERD symptom control.

* POPULATION STUDIED The patient population for this study consisted of 3510 individuaL'; over age 18 years with endoscopically confirmed erosive esophagitis of grade 2 .severity or higher who were gathered through a large multicenter clinical trial. To enter the study, patients had to have experienced at least 1 episode of moderate to very severe heartburn within 3 days before their screening visit. Comparison of treatment groups showed the only significant demographic difference was increased reported tobacco use in the omeprazole group (28%) versus the lansoprazole group (25%).

* STUDY DESIGN AND VALIDITY This study was a double-blind multicenter clinical trial in which participants were randomized to receive either 30 mg lansoprazole or 20 mg omeprazole once daily for 8 weeks. Allocation concealment was not mentioned. Follow-up visits were conducted at the end of weeks 1, 2, and 8 of treatment. Analysis was by intention to treat.

This study was well designed overall. The .,;ample size was large enough to detect small differences between lansoprazole and omeprazole.

* OUTCOMES MEASURED This study looked primarily at onset and duration of symptom relief and severity as recorded by patients in a diary. Specifically, daytime and nighttime heartburn symptoms were analyzed with regard to percentage of complete heartburn relief as well as average heartburn severity at days 1 to 3 and the end of weeks 1, 2, and 8 of treatment.

* RESULTS The group treated with lansoprazole showed a statistically significant advantage in symptom relief throughout the treatment period. On day 1 of treatment, the lansoprazole group was found to be 33% heartburn free as compared with 25% in the omeprazole group (P < .0001). The number needed to treat (NNT) to see this statistically significant difference was 12.5. Patients receiving lansoprazole versus omeprazole had small but statistically significant decreases in numbers of heartburn-free days (56% vs 49% in first 3 days of treatment, NNT = 14) and nights (NNT = 14) as well as daytime heartburn severity and nighttime severity. The lansoprazole-treated group also showed increased sustained resolution of symptoms over the omeprazole-treated group during the 8-week study period. Overall, however, these differences were extremely small and narrowed as the study progressed to 8 weeks.

RECOMMENDATIONS FOR CLINICAL PRACTICE

Lansoprazole provided a small but sustained advantage over omeprazole in the treatment of heartburn. However, although statistically significant, these differences in efficacy are minor and diminished over the 8-week course of treatment. In deciding to use one PPI over another, clinicians should consider other factors, primarily cost or availability.
Jeffrey D. Kim, MD
University of Washington Family
Practice Residency Program
Seattle
E-mail: jeffkim@u.washington.edu

COPYRIGHT 2002 Appleton & Lange
COPYRIGHT 2002 Gale Group

Mailbox

I read with great interest Wolfgang Dehling's comment ("Mailbox, July) regarding the two Australian swimmers in 1984 and 1988 who came from nowhere to win gold medals and break world records, then disappeared back to nowhere.

"Was this only because of their `fighting spirit'?" Dehling asks.

His rhetorical question got me to do a little research. I wondered what Jon Sieben (upset 200 fly winner of the '84 Olympic gold at L.A. in a then world record 1:54.04) and Duncan Armstrong (surprise winner of the Olympic gold 200 free in a world record 1:47.25 at Seoul in '88) had done the year before and the year after their once-in-a-lifetime triumphs?

The answer: not much.

Sieben in '83 was tied for 25th globally with a then personal best of 2:01.98 - meaning he dropped nearly five seconds in less than a year! Armstrong tied for 24th in the world in '87 with a1:50+, which means he dropped more than three-and-a-half seconds at Seoul. And the year after his stirring Olympic triumph, he was not among the top 25 globally in his speciality.

Interesting, too, is the fact that Sieben has one time only-his world record-on the all-time world performances list, and my cut goes down to 1:58.5 for some 300-deep! Armstrong has two times among the all-time top 250-plus performances-his WR and his prelim time at Seoul of 1:48.88, which ranks somewhere in the high 150-160s (my cut is 1:49.19).

The point is that while only the swimmers, their coaches and FINA know for sure what the duo sprinkled on their Wheaties those fateful mornings, both Sieben and Armstrong did times at L.A. and Seoul that they never came close to equalling again, unlike, say, a Kieren Perkins or a Michael Klim, who consistently swim fast over a long period of time.

BILL BELL

Los Angeles, California

The Fats About Mesterolone am concerned about some information you reported in the "Lane 9" section of the June issue of SW. It was stated that Jessica Foschi tested positive for "mesterolone, a steroid that is not performance-enhancing." The fact is that mesterolone is an orally active derivative of dihydrotestosterone, which has significant anabolic properties while remaining a low risk for liver toxicity-an ideal drug for athletic performance enhancement.

My concern is that the article is either (I) erroneously making the claim that some anabolic steroids are not performance-enhancing, (2) suggesting that some substances, although they are banned for everyone, do not benefit swimmers in certain events, or (3) making an attempt to sanitize the story because the athlete is an American.

Perhaps the name of the steroid was an error, and her sample tested positive for an anti-inflammatory corticosteroid, not the anabolic steroid mesterolone. In any case, since your magazine has taken a pro-active stance on the "drug issue" and many people look to Swimming World for accurate information, I sincerely hope you will print a correction or an explanation.

TIM DeMOTT

Via E-Mail

The editor replies:

Our statement regarding mesterolone, which we've made before, comes from several experts who describe the drug as one used by body builders to enhance the cut of their muscles. Apparently, it is not one of the anabolic steroids used to increase strength.

Copyright Sports Publications, Inc. Sep 1998
Provided by ProQuest Information and Learning Company. All rights Reserved

Tuesday, May 22, 2007

Danazol may be linked to rise in ovarian cancer, small study finds - Risk raised two-to threefold

MIAMI BEACH--Danazol use may be associated with increased risk for ovarian cancer, the results of a small study suggest.

In the study, which included pooled data from two case-control studies, women who used danazol were nearly three times more likely to develop ovarian cancer than were those using leuprolide, Dr. Roberta B. Ness reported at the annual meeting of the Society of Gynecologic Oncologists.

Of 1,373 women with ovarian cancer, 195 also had endometriosis; of 1,980 control patients without ovarian cancer, 195 had endometriosis. Of the 195 ovarian cancer/endometriosis patients, 12 had used the synthetic androgen danazol to treat their endometriosis, and 8 had used the antiandrogenic gonadotropin-releasing hormone agonist Lupron; of the 195 controls, 5 had used danazol, and 7 had used leuprolide, said Dr. Ness of the University of Pittsburgh.

Previous studies have shown that women with endometriosis have up to a 50% greater risk of developing ovarian cancer than other women. In this study, women with endometriosis were 1.5-fold more likely to develop ovarian cancer. The use of danazol seems to further increase the risk of ovarian cancer in women with endometriosis, said Dr. Ness, who is also director of the Epidemiology of Women's Health Program at the university.

Among all of the patients, leuprolide use was found to be associated with a slightly increased risk of ovarian cancer (odds ratio 1.4), but Dr. Ness attributed that finding to the fact that most of the women using leuprolide had endometriosis. In an analysis of only the women with endometriosis, the association diminished (odds ratio 1.2), she noted at the meeting, also sponsored by the American College of Surgeons.

Danazol use, however, increased the risk of ovarian cancer substantially, both in the entire study population (odds ratio 3.6) and in those with endometriosis (odds ratio 2.3).

Repeated telephone calls seeking comment on the study were not returned by New York-based Sanofi-Synthelabo Inc., which manufacturers a widely used brand name formulation of danazol called Danocrine.

The findings support the hypothesis that androgens play a role in ovarian cancer, and while the number of women treated with danazol and leuprolide in this study was small, the findings raise concerns that warrant further study of potential risks tied to danazol.

COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2002 Gale Group
by Sharon Worcester

Overdose of acetaminophen, AKA Tylenol, the leading cause of acute liver failure in the U.S

Overdose of the over-the-counter painkiller acetaminophen (Tylenol) is the leading cause of acute liver failure, a catastrophic illness that can rapidly lead to coma and death. A new study found that unintentional overdose accounted for nearly half the cases, with attempted suicides making up most of the rest.

A. M. Larson, MD, University of Washington Medical Center, Seattle, studied 662 consecutive patients with acute liver failure who had been admitted to one of 22 critical care centers in the U.S. between 1998 and 2003. The findings, which appeared in the December 2005 issue of Hepatology, showed that the yearly percentage of acetaminophen-related acute liver failure had climbed from 28% in 1998 to 51% in 2003. Besides the 74 patients who died as a result of the acetaminophen-related acute liver failure, 23 others needed a liver transplant in order to survive.

In most of the unintentional overdose cases, the people had been taking acetaminophen regularly for acute or chronic pain, and 38% took two or more acetaminophen products simultaneously. (Many people are unaware that certain prescription painkillers like Vicodin or Percocet and over-the-counter products like TheraFlu contain acetaminophen.) The written instructions that come with each package of acetaminophen tell consumers not to exceed four grams a day, but the median dose ingested by people in this study was 24 grams, or the equivalent of 48 extra-strength tablets.

Over the years, the FDA has identified the circumstances most likely to result in harm due to exceeding the safe-dose limit. They include age (over 65), alcoholism, concomitant use of alcohol, anticoagulants, and corticosteroids, and illnesses such as kidney disease, congestive heart failure, and diabetes.

The Philadelphia-based Institute for Safe Medication Practices reported in 2002 that 27,000 cases of accidental acetaminophen overdose occur in children annually, though fatalities are rare. A leading cause is misreading of the label instructions. Parents often do not realize that acetaminophen infant drops are a far more concentrated than the liquid acetaminophen product intended for older children.

COPYRIGHT 2006 Center for Medical Consumers, Inc.
COPYRIGHT 2006 Gale Group
Healthfacts

Antihypertensive Drugs

Definition

Antihypertensive drugs are medicines that help lower blood pressure.

Purpose

All antihypertensive agents lower blood pressure, although the mechanisms of action vary greatly. Within this therapeutic class, there are several subgroups. There are a very large number of drugs used to control hypertension, and the drugs listed below are representatives, but not the only members of their classes.

Description

The calcium channel blocking agents, also called slow channel blockers or calcium antagonists, inhibit the movement of ionic calcium across the cell membrane. This reduces the force of contraction of heart muscles and arteries. Although the calcium channel blockers are treated as a group, there are four different chemical classes, leading to significant variations in the activity of individual drugs. Nifedipine (Adalat, Procardia) has the greatest effect on the blood vessels, while verapamil (Calan, Isoptin) and diltiazem (Cardizem) have a greater effect on the heart muscle itself.

Peripheral vasodilators such as hydralazine (Apresoline), isoxuprine (Vasodilan), and minoxidil (Loniten) act by relaxing blood vessels.

There are several groups of drugs that act by reducing adrenergic nerve stimulation, the excitatory nerve stimulation that causes contraction of the muscles in the arteries, veins, and heart. These drugs include the beta-adrenergic blockers and alpha/beta adrenergic blockers. There are also non-specific adrenergic blocking agents.

Beta-adrenergic blocking agents include propranolol (Inderal), atenolol (Tenormin), and pindolol (Visken). Propranolol acts on the beta-adrenergic receptors anywhere in the body, and has been used as a treatment for emotional anxiety and rapid heart beat. Atenolol and acebutolol (Sectral) act specifically on the nerves of the heart and circulation.

There are two alpha/beta adrenergic blockers, labetolol (Normodyne, Trandate) and carvedilol (Coreg). These work similarly to the beta blockers.

Angiotensin-converting enzyme inhibitors (ACE inhibitors) act by inhibiting the production of angiotensin II, a substance that induces both constriction of blood vessels and retention of sodium, which leads to water retention and increased blood volume. There are 10 ACE inhibitors currently marketed in the United States, including captopril (Capoten), benazepril (Lotensin), enalapril (Vasotec), and quinapril (Acupril). The primary difference between these drugs is their onset and duration of action.

The ACE II inhibitors, losartan (Cozaar), candesartan (Atacand), irbesartan (Avapro), telmisartan (Micardis), valsartan (Diovan), and eprosartan (Teveten) directly inhibit the effects of ACE II rather than blocking its production. Their actions are similar to the ACE inhibitors, but they appear to have a more favorable side effect and safety profile.

In addition to these drugs, other classes of drugs have been used to lower blood pressure, most notably the thiazide diuretics . There are 12 thiazide diuretics marketed in the United States, including hydrochlorothiazide (Hydrodiuril, Esidrex), indapamide (Lozol), polythiazide (Renese), and hydroflumethiazide (Diucardin). The drugs in this class appear to lower blood pressure through several

Antihypertensive Drugs Brand Name (Generic Name) Possible Common Side Effects Include: Accupril (quinapril hydrochloride) Headache, dizziness Aldatazide Diarrhea, fever, headache, decreased coordination Aldactone (spironolactone) Cramps, drowsiness, stomach disorders Aldomet (methyldopa) Fluid retention, headache, weak feeling Altace (ramipril) Headache, cough Calan, Calan SR (verapamil hydrochloride) Constipation, fatigue, decreased blood pressure Capoten (captopril) Decreased sense of taste, decreased blood pressure tiching, rash Cardene (nicardipine Hydrochloride) Dizziness, headache, indigestion and nausea, increased heartbeat Cardizem (diltiazem hydrochloride) Dizziness, fluid retention, headache, nausea, skin rash Cardura (doxazosin mesylate) Dizziness, fatigue, drowsiness, headache Catapres Dry mouth, drowsiness, dizziness, constipation Corgard (nadolol) Behaviorial changes, dizziness, decreased heartbeat, tiredness Corzide Dizziness, decreased heartbeat, fatigue, cold hands and feet Diuril (chlorothiazide) Cramps, constipation or diarrhea, dizziness, fever, increased glocose level in urine Dyazide Blurred vision, muscle and abdominal pain, fatigue DynaCirc (isradipine) Chest pain, fluid retention, headache, fatigue HydroDIURIL (hydrochlorothiazide) Upset stomach, headache, cramps, loss of appetite Hygroton (chlorthalidone) Anemia, constipation or diarrhea, cramps, itching Hytrin (terazosin hydrochloride) Dizziness, labored breathing, nausea, swelling Inderal (propranolol hydrochloride) Constipation or diarrhea, tingling sensation, nausea and vomiting Inderide Blurred vision, cramps, fatigue, loss of appetite Lasix (furosemide) Back and muscle pain, indigestion, nausea Lopressor (metoprolol tartrate) Diarrhea, itching/rash, tiredness Lotensin (benazepril hydrochloride) Nausea, dizziness, fatigue, headache Alozol (indapamide) Anxiety, headache, loss of energy, muscle cramps Maxzide Cramps, labored breathing, drowsiness, irritated stomach Minipress (prazosin hdrochloride) Headache, nausea, weakness, dizziness Moduretic Diarrhea, fatigue, itching, loss of appetite Monopril (fosinopril sodium) Nausea and vomiting, headache, cough Normodyne (labetalol hydrochloride) Fatigue, nausea, stuffy nose Plendil (felodipine) Pain in back, chest, muscles, joints, and abdomen, itching, dry mouth, respiratory problems Procardia, Procardia X (nifedipine) Swelling, constipation, decreased blood pressure, nausea, fatigue Sectral (acebutolol hydrochloride) Constipation or diarrhea, gas, chest and joint pain Ser-Ap-Es Blurred vision, cramps, muscle pain, dizziness Tenex (guanfacine hydrochloride) Headache, constipation, dry mouth, weakness Tenoretic Decreased heartbeat, fatigue, nausea Tenormin (atenolol) Nausea, fatigue, dizziness Veseretic Diarrhea, muscle cramps, rash Vasotec (enalapril maleate) Chest pain, blurred vision, constipation or diarrhea, hives, nausea Visken (pindolol) Muscle cramps, labored breathing, nausea, fluid retention Wytensin (guanabenz acetate) Headache, drowsiness, dizziness Zaroxolyn (metolazone) Constipation or diarrhea, chest pain, spasms, nausea Zestoretic (lisinopril hydrochlorothiazide) Fatigue, headache, dizziness Zestril (lisinopril) Labored breathing, abdominal and chest pain, nausea, decreased blood pressure
mechanisms. By promoting sodium loss they lower blood volume. At the same time, the pressure of the walls of blood vessels, the peripheral vascular resistance, is lowered. Thiazide diuretics are commonly used as the first choice for reduction of mild hypertension, and may be used in combination with other antihypertensive drugs.

Sodium nitroprusside (Nitropress) and diazoxide (Hyperstat) are used for rapid treatment of hypertensive emergencies. They are given by vein, often during surgery, to reduce blood pressure that suddenly becomes elevated.

Many classes of antihypertensive drugs have been used before surgery to maintain a low blood pressure during the procedure. There does not appear to be a significant difference between drugs when they are used for blood pressure reduction during surgery.

Recommended dosage

Recommended dosage varies with patient, drug, severity of hypertension, and whether the drug is being used alone or in combination with other drugs. Patients should consult specialized references or ask a physician for further information.

Precautions

The warnings and precautions given below apply to the use of antihypertensive drugs over a long period of time. These adverse effects are generally not a problem when the drugs are given as a single dose prior to surgery.

Because of the large number of classes and individual drugs in this group, patients should ask their physicians about specific drugs.

Peripheral vasodilators may cause dizziness and orthostatic hypotension—a rapid lowering of blood pressure when the patient stands up in the morning. Patients taking these drugs must be instructed to rise from bed slowly. Pregnancy risk factors for this group are generally category C, meaning they may result in adverse affects on the fetus. Hydralazine has been shown to cause cleft palate in animal studies, but there is no human data available. Breastfeeding is not recommended.

ACE inhibitors are generally well tolerated, but may rarely cause dangerous reactions including laryngospasm and angioedema. Persistent cough is a common side effect. ACE inhibitors should not be used in pregnancy. When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury to and even death in the developing fetus. When pregnancy is detected, discontinue the ACE inhibitor as soon as possible. Breastfeeding is not recommended.

ACE II inhibitors are generally well tolerated and do not cause cough. Pregnancy risk factor is category C during the first trimester and category D (known to cause adverse effects in the fetus) during the second and third trimesters. Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in patients who were taking ACE inhibitors. When pregnancy is detected, discontinue ACE inhibitors as soon as possible. Breast-feeding is not recommended.

Thiazide diuretics commonly cause potassium depletion. Patients should have potassium supplementation either through diet, or potassium supplements. Pregnancy risk factor is category B (chlorothiazide, chlorthalidone, hydrochlorothiazide, indapamide, metolazone) or category C (bendroflumethiazide, benzthiazide, hydroflumethiazide, methyclothiazide, trichlormethiazide). Routine use during normal pregnancy is inappropriate. Thiazides are found in breast milk. Breastfeeding is not recommended.

Beta blockers may cause a large number of adverse reactions including dangerous heart rate abnormalities. Pregnancy risk factor is category B (acebutolol, pindolol, sotalol) or category C (atenolol, labetalol, esmolol, metoprolol, nadolol, timolol, propranolol, penbutolol, carteolol, bisoprolol). Breastfeeding is not recommended.

Interactions

Patients should ask their doctors and consult specific references for food and drug interactions.

by Samuel Uretsky

Updated CDC guidelines for the treatment of STDs

Guideline source: Centers for Disease Control and Prevention

Literature search described? Yes

Evidence rating system used? No

Published source: Morbidity and Mortality Weekly Report, August 4, 2006

Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5511a1.htm

**********

The Centers for Disease Control and Prevention (CDC) updated its 2002 guidelines for the treatment of sexually transmitted diseases (STDs) after consultation with professionals and a systematic review of the evidence. The updated guidelines contain new approaches to patient-centered counseling, expanded discussions of prevention screening for human immunodeficiency virus (HIV) and other STDs, and several diagnosis and treatment updates, discussed below.

Approaches to Prevention

The five strategies for the prevention of STDs are: education and counseling of persons at risk; (2) identification of infected persons who are asymptomatic and those who are symptomatic but unlikely to seek treatment; (3) effective diagnosis and treatment of infected persons; (4) evaluation, treatment, and counseling of sex partners of infected persons; and (5) preexposure vaccination of persons at risk, when possible.

Physicians should routinely obtain sexual histories from patients and address risk-reduction management. thorough sexual history and effective delivery of prevention messages require counseling skills marked by respect, compassion, and a nonjudgmental attitude. Effective techniques include the use of open-ended questions (e.g., "Tell me about any sex partners you've had since your last visit," "What has your experience with using condoms been like?"), understandable language g., "Have you ever had a sore or scab on your penis?"), and normalizing language (e.g., "Some of my patients have difficulty always using a condom. How is it for you?"). One approach to obtaining information is the Five Ps: Partners, Prevention of pregnancy, Protection from STDs, Practices, and Past history of STDs (Table 1).

Prevention counseling should incorporate risk-reduction messages that are relevant to the patient as well as education about specific actions that can reduce STD risk, such as abstinence, condom use, fewer sex partners, modifying sexual behaviors, and vaccination when appropriate. Guidance on prevention counseling and effective interventions is available at http://www.stdhivprevention training.org and http://effectiveinterventions.org.

Physicians should reassure patients that treatment will be provided regardless of their circumstances (e.g., ability to pay). Although many patients requiring screening or treatment for one specific STD should be assessed for all common STDs, patients should be informed of all STDs for which they are being tested and of common STDs for which testing is not being performed.

HIV Screening

All persons who seek evaluation and treatment for STDs should be screened for HIV infection, regardless of risk factors. Consent for HIV testing should be incorporated into the general consent for care. HIV testing must be voluntary and conducted only with the patient's knowledge and understanding. However, it should be performed on an opt-out basis--patients should be informed orally or in writing that, unless they decline, HIV testing will be performed. An explanation of positive and negative test results should be given, and patients should have the opportunity to ask questions and decline testing.

HIV testing may be a good opportunity for prevention counseling to encourage and help with behavior changes; prevention counseling should be encouraged at all facilities that serve patients at high risk or that routinely obtain information on HIV risk behaviors.

HIV rapid testing allows a presumptive diagnosis of HIV-1 infection within 30 minutes and must be considered, particularly in clinics where many patients do not return for results. Positive results for HIV antibody screening must be confirmed by an additional test, such as the Western blot or an immunofluorescence assay. Patients with positive results on confirmatory tests must be given initial HIV prevention counseling before they leave the testing site. They should also receive a medical evaluation and, if indicated, behavioral and psychological services or a referral for these services.

Physicians should be alert to acute retroviral syndrome, which often occurs in the first few weeks after HIV infection, and should perform nucleic acid testing for HIV if indicated. Symptoms and signs of acute retroviral syndrome include fever, malaise, lymphadenopathy, and skin rash. HIV infection may be more easily transmitted in acutely infected persons, and these persons may still be practicing risky behaviors. Patients with recently acquired HIV infection may benefit from antiretroviral drugs and could be candidates for clinical trials; therefore, these patients should be referred for immediate consultation with an HIV subspecialist.

Because the incidence of STDs has increased in persons infected with HIV, consensus guidelines emphasize that STD and HIV risk assessment, STD screening, and patient-centered risk-reduction counseling should be provided routinely to all patients with HIV infection. Specific approaches for HIV care are described at http://effective interventions.org.

A summary of treatment recommendations for select conditions is provided in Table 2. Physicians should refer to the full guidelines for recommendations on the treatment of syphilis.

Updates to diagnosis and treatment recommendations include expanded diagnostic evaluations for cervicitis and trichomoniasis, as well as discussion of the roles of Mycoplasma genitalium and trichomoniasis in urethritis and cervicitis. Urethritis with M. genitalium infection may respond better to azithromycin (Zithromax) than doxycycline (Vibramycin). Recommended treatment regimens for persistent urethritis include tinidazole (Tindamax) and the addition of azithromycin. Tinidazole also is recommended for treatment of trichomoniasis.

The new guidelines cite further data on the effectiveness of azithromycin for chlamydial infection during pregnancy, and azithromycin is the primary recommended regimen for this indication. The increasing prevalence of quinolone-resistant Neisseria gonorrhoeae in men who have sex with men is discussed, with new recommendations for treating gonococcal infections in these patients (the CDC Web site contains up-to-date information on quinolone resistance at http://www.cdc.gov/std/gisp).

Other additions include expanded discussion of the criteria for spinal fluid examination in neurosyphilis evaluation; new discussions of lymphogranuloma venereum proctocolitis in men who have sex with men and the emergence of azithromycin-resistant Treponema pallidum; and revised discussions of the sexual transmission of hepatitis C and postexposure prophylaxis after sexual assault.

TABLE 1
The Five Ps: An Approach to Taking a Sexual History

Partners

"Do you have sex with men, women, or both?"
"In the past two months, how many partners have you had sex with?"
"In the past 12 months, how many partners have you had sex with?"

Prevention of pregnancy

"Are you or your partner trying to get pregnant?"
If the answer is no, "What are you doing to prevent pregnancy?"

Protection from STDs

"What do you do to protect yourself from STDs and HIV?"

Practices

"To understand your risks of STDs, I need to understand the kind of
sex you have had recently."
"Have you ever had vaginal sex, meaning 'penis in vagina sex'?"
If the answer is yes, "Do you use condoms never, sometimes, or always?"
"Have you had anal sex, meaning 'penis in rectum/anus sex'?"
If the answer is yes, "Do you use condoms never, sometimes, or always?"
"Have you had oral sex, meaning 'mouth on penis or vagina'?"
For answers to condom questions:

If the answer is never, "Why don't you use condoms?"
If the answer is sometimes, "In what situations, or with whom,
do you not use condoms?"

Past history of STDs

"Have you ever had an STD?"
"Have any of your partners had an STD?"
Additional questions to identify HIV and hepatitis risk:

"Have you or your partners ever injected drugs?"
"Have you or your partners exchanged money or drugs for sex?"
"Is there anything else about your sexual practices that I
need to know about?"

STD = sexually transmitted disease; HIV = human immunodeficiency virus.

Information from Centers for Disease Control and Prevention. Sexually
transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep
2006;55(RR-11):1-94.

TABLE 2
Treatment Recommendations for Sexually Transmitted Diseases

Indication Recommended treatments

Bacterial vaginosis

Nonpregnant patients Metronidazole (Flagyl) 500 mg orally two
times per day for seven days
Metronidazole 0.75% gel 5 g (one full
applicator) intravaginally once per day
for seven days
Clindamycin (Cleocin) 2% cream 5 g (one
full applicator) intravaginally at
bedtime for seven days

Alternatives:
Clindamycin 300 mg orally two times per
day for seven days
Clindamycin ovules 100 mg intravaginally
once at bedtime for three days

Pregnant patients Metronidazole 500 mg orally two times per
day for seven days
Metronidazole 250 mg orally three times
per day for seven days
Clindamycin 300 mg orally two times per
day for seven days

Cervicitis, presumptive Azithromycin (Zithromax) 1 g orally in a
single dose
Doxycycline (Vibramycin) 100 mg orally
two times per day for seven days plus
consider concurrent treatment for
gonococcal infection

Chancroid Azithromycin 1 g orally in a single dose
Ceftriaxone (Rocephin) 250 mg IM in a
single dose
Ciprofloxacin (Cipro) 500 mg orally two
times per day for three days
Erythromycin base 500 mg orally three
times per day for seven days

Chlamydia

Nonpregnant adults Azithromycin 1 g orally in a single dose
Doxycycline 100 mg orally two times per
day for seven days
Alternatives:
Erythromycin base 500 mg orally four
times per day for seven days
Erythromycin ethylsuccinate 800 mg
orally four times per day for seven
days
Ofloxacin (Floxin) 300 mg orally two
times per day for seven days
Levofloxacin (Levaquin) 500 mg orally
once per day for seven days

Pregnant women Azithromycin 1 g orally in a single dose
Amoxicillin 500 mg orally three times per
day for seven days
Alternatives:
Erythromycin base 500 mg orally four
times per day for seven days
Erythromycin base 250 mg orally four
times per day for 14 days
Erythromycin ethylsuccinate 800 mg
orally four times per day for seven
days
Erythromycin ethylsuccinate 400 mg
orally four times per day for 14 days

Epididymitis, acute

Caused by gonococcal or Ceftriaxone 250 mg IM in a single dose
chlamydial infection plus doxycycline 100 mg orally two
times per day for 10 days

Caused by enteric Ofloxacin 300 mg orally two times per day
organisms for 10 days
Levofloxacin 500 mg orally once per day
for 10 days

Gonococcal infection, Ceftriaxone 125 mg IM in a single dose
genital Cefixime (Suprax) 400 mg orally in a
single dose
Ciprofloxacin 500 mg orally in a single
dose *
Ofloxacin 400 mg orally in a single dose *
Levofloxacin 250 mg orally in a single
dose * plus treatment for chlamydial
infection, if not ruled out

Granuloma inguinale Doxycycline 100 mg orally twice per day
(donovanosis) for at least three weeks and until all
lesions have healed completely
Alternatives:
Azithromycin 1 g orally once per week
for at least three weeks
Ciprofloxacin 750 mg orally two times
per day for at least three weeks
Erythromycin base 500 mg orally four
times per day for at least three weeks
Trimethoprim/sulfamethoxazole (Bactrim,
Septra) 160/800 mg (one double-
strength tablet) orally two times per
day for at least three weeks

Herpes, genital
First episode Acyclovir (Zovirax) 400 mg orally three
times per day for seven to 10 days
Acyclovir 200 mg orally five times per
day for seven to 10 days
Famciclovir (Famvir) 250 mg orally three
times per day for seven to 10 days
Valacyclovir (Valtrex) 1 g orally twice
per day for seven to 10 days
NOTE: Treatment can be extended if
healing is incomplete after 10 days of
therapy

Suppressive therapy Acyclovir 400 mg orally twice per day
Famciclovir 250 mg orally twice per day
Valacyclovir 500 mg orally once per day
Valacyclovir 1 g orally once per day

Recurrent therapy Acyclovir 400 mg orally three times per
day for five days
Acyclovir 800 mg orally twice per day for
five days
Acyclovir 800 mg orally three times per
day for two days
Famciclovir 125 mg orally two times per
day for five days
Famciclovir 1 g orally two times per day
for one day
Valacyclovir 500 mg orally two times per
day for three days
Valacyclovir 1 g orally once per day for
five days

Lymphogranuloma Doxycycline 100 mg orally two times per
venereum day for 21 days
Alternative:
Erythromycin base 500 mg orally four
times per day for 21 days

Pelvic inflammatory disease

Parenteral Cefotetan (Cefotan) 2 g IV every 12 hours
plus doxycycline 100 mg orally
(preferred) or IV every 12 hours
Cefoxitin (Mefoxin) 2 g IV every six
hours plus doxycycline 100 mg orally
(preferred) or IV every 12 hours
Clindamycin 900 mg IV every eight hours
plus gentamicin loading dose 2 mg per
kg IV or IM then maintenance dose 1.5
mg per kg every eight hours (single
daily dosing may be substituted)
Alternatives:
Levofloxacin 500 mg IV once per day *
with or without metronidazole 500 mg
IV every eight hours
Ofloxacin 400 mg IV every 12 hours *
with or without metronidazole 500 mg
IV every eight hours
Ampicillin/sulbactam (Unasyn) 3 g IV
every six hours plus doxycycline 100
mg orally or IV every 12 hours

Oral Levofloxacin 500 mg orally once per day
for 14 days *
Ofloxacin 400 mg orally two times per day
for 14 days *
Ceftriaxone 250 mg IM in a single dose
plus doxycycline 100 mg orally two
times per day for 14 days
Cefoxitin 2 g IM in a single dose and
probenecid 1 g orally in a single dose
administered concurrently plus doxy-
cycline 100 mg orally two times per day
for 14 days
Other parenteral third-generation
cephalosporin (e.g., ceftizoxime,
cefotaxime) plus doxycycline 100 mg
orally two times per day for 14 days
with or without metronidazole 500 mg
orally two times per day for 14 days

Prophylaxis after Ceftriaxone 125 mg IM in a single dose
sexual assault Metronidazole 2 g orally in a single dose
Azithromycin 1 g orally in a single dose
Doxycycline 100 mg orally two times per
day for seven days

Trichomoniasis Metronidazole 2 g orally in a single dose
Tinidazole (Tindamax) 2 g orally in a
single dose
Alternative:
Metronidazole 500 mg orally two times
per day for seven days

Urethritis, nongonococcal Azithromycin 1 g orally in a single dose
Doxycycline 100 mg orally two times per
day for seven days
Alternatives:
Erythromycin base 500 mg orally four
times per day for seven days
Erythromycin ethylsuccinate 800 mg
orally four times per day for seven
days
Ofloxacin 300 mg orally two times per
day for seven days
Levofloxacin 500 mg orally one per day
for seven days

IM = intramuscularly; IV = intravenously.

*--Quinolones should not be used in men who have sex with men, those
with a history of foreign travel (themselves or a partner), or those
with infections acquired in California, Hawaii, or other areas with
increased prevalence of resistant organisms.

Information from Centers for Disease Control and Prevention. Sexually
transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep 2006;


COPYRIGHT 2007 American Academy of Family Physicians
COPYRIGHT 2007 Gale Group
by Liz Smith

Prozac as a Way of Life

PROZAC AS A WAY OF LIFE Carl Elliott and Tod Chambers, eds. (University of North Carolina Press)

Prozac, and its newer variants, can help well-adjusted people feel "better than well"--more focused, more enthusiastic and more fulfilled. But should that be encouraged? The editors bring together a world-class group of doctors, philosophers and ethicists to explore the implications of medically enhanced life. This volume is not for beginners, though--designed to further an on-going conversation about treating the healthy, it doesn't pause to bring newcomers to the debate up to speed.

COPYRIGHT 2004 Sussex Publishers, Inc.
COPYRIGHT 2004 Gale Group
Psychology Today

Immunosuppressant Drugs

Immunosuppressant drugs

Definition

Immunosuppressant drugs, which are also called anti-rejection drugs, are used to prevent the body from rejecting a transplanted organ.

Purpose

In addition to being used to prevent organ rejection, immunosuppressant drugs are also used to treat such severe skin disorders as psoriasis and such other diseases as rheumatoid arthritis, Crohn's disease (chronic inflammation of the digestive tract), and patchy hair loss (alopecia areata). Some of these conditions are termed "autoimmune" diseases, indicating that the immune system is reacting against the body itself.

Description

Immunosuppressant drugs can be classified according to their specific molecular mode of action. The four main categories of immunosuppressant drugs currently used in treating patients with transplanted organs are the following:

Cyclosporins (Neoral, Sandimmune, SangCya). These drugs act by inhibiting T-cell activation, thus preventing T-cells from attacking the transplanted organ. Azathioprines (Imuran). These drugs disrupt the synthesis of DNA and RNA as well as the process of cell division. Monoclonal antibodies, including basiliximab (Simulect), daclizumab (Zenpax), and muromonab (Orthoclone OKT3). These drugs act by inhibiting the binding of interleukin-2, which in turn slows down the production of T-cells in the patient's immune system. Such corticosteroids as prednisolone (Deltasone, Orasone). These drugs suppress the inflammation associated with transplant rejection.

Most patients are prescribed a combination of drugs after their transplant, one from each of the above main groups; for example, they may be given a combination of cyclosporin, azathioprine, and prednisolone. Over a period of time, the doses of each drug and the number of drugs taken may be reduced as the risks of rejection decrease. Most transplant patients, however, will need to take at least one immunosuppressive medication for the rest of their lives.

Immunosuppressants can also be classified according to the specific organ that is transplanted:

Basiliximab (Simulect) is also used in combination with such other drugs as cyclosporin and corticosteroids in kidney transplants. Daclizumab (Zenapax)is also used in combination with such other drugs as cyclosporin and corticosteroids in kidney transplants. Muromonab CD3 (Orthoclone OKT3) is used along with cyclosporin in kidney, liver and heart transplants. Tacrolimus (Prograf) is used in liver and kidney transplants. It is under study for bone marrow, heart, pancreas, pancreatic island cell, and small bowel transplantation

Some immunosuppressants are also used to treat a variety of autoimmune diseases:

Azathioprine (Imuran) is used not only to prevent organ rejection in kidney transplants, but also in treatment of rheumatoid arthritis. It has been used to treat chronic ulcerative colitis, although it has proved to be of limited value for this use. Cyclosporin (Sandimmune, Neoral) is used in heart, liver, kidney, pancreas, bone marrow, and heart/lung transplantation. The Neoral form of cyclosporin has been used to treat psoriasis and rheumatoid arthritis. The drug has also been used to treat many other conditions, including multiple sclerosis, diabetes, and myasthenia gravis. Glatiramer acetate (Copaxone) is used in the treatment of relapsing-remitting multiple sclerosis. In one study, glatiramer reduced the frequency of multiple sclerosis attacks by 75% over a two-year period. Mycopehnolate (CellCept) is used along with cyclosporin in kidney, liver, and heart transplants. It has also been used to prevent the kidney problems associated with lupus erythematosus. Sirolimus (Rapamune) is used in combination with other drugs, including cyclosporin and corticosteroids, in kidney transplants. The drug is also used to treat patients with psoriasis.

Recommended dosage

Immunosuppressant drugs are available only with a physician's prescription. They come in tablet, capsule, liquid, and injectable forms. The recommended dosage depends on the type and form of immunosuppressant drug and the purpose for which it is being used. Doses may be different for different patients. The prescribing physician or the pharmacist who filled the prescription will advise the patient on the correct dosage.

Patients should always consult the prescribing physician before they stop taking an immunosuppressant drug.

Precautions

Patients who are taking immunosuppressant drugs should see their doctor on a regular basis. Periodic checkups will allow the physician to make sure the drug is working as it should and to monitor the patient for unwanted side effects. These drugs are very powerful and can cause such serious side effects as high blood pressure, kidney problems and liver disorders. Some side effects may not show up until years after the medicine was used. Anyone who has been advised to take immunosuppressant drugs should thoroughly discuss the risks and benefits of these medications with the prescribing physician.
Immunosuppressant drugs lower a person's resistance to infection and can make infections harder to treat. The drugs can also increase the chance of uncontrolled bleeding. Anyone who has a serious infection or injury while taking immunosuppressant drugs should get prompt medical attention and should make sure that the treating physician knows that he or she is taking an immunosuppressant medication. The prescribing physician should be immediately informed if such signs of infection as fever or chills; cough or hoarseness; pain in the lower back or side; painful or difficult urination; bruising or bleeding; blood in the urine; bloody or black, tarry stools occur. Other ways of preventing infection and injury include washing the hands frequently, avoiding sports in which injuries may occur, and being careful when using knives, razors, fingernail clippers, or other sharp objects. Avoiding contact with people who have infections is also important.

In addition, people who are taking or have been taking immunosuppressant drugs should not have such immunizations as smallpox vaccinations without consulting their physician. Because their resistance to infection has been lowered, people taking these drugs might get the disease that the vaccine is designed to prevent. People taking immunosuppressant drugs should avoid contact with anyone who has had a recent dose of oral polio vaccine, as there is a chance that the virus used to make the vaccine could be passed on to them.

Immunosuppressant drugs may cause the gums to become tender and swollen or to bleed. If this happens, a physician or dentist should be notified. Regular brushing, flossing, cleaning, and gum massage may help prevent this problem. A dentist can provide advice on how to clean the teeth and mouth without causing injury.

Special conditions

People who have certain diseases or disorders, or who are taking certain other medicines may have problems if they take immunosuppressant drugs. Before taking these drugs, patients should inform the prescribing physician about any of the following conditions:

ALLERGIES. Anyone who has had unusual reactions to immunosuppressant drugs in the past should let his or her physician know before taking the drugs again. The physician should also be told about any allergies to foods, dyes, preservatives, or other substances.

PREGNANCY. Azathioprine has been considered a cause of birth defects. The British National Formulary, however, states: "Transplant patients immunosuppressed with azathioprine should not discontinue it on becoming pregnant; there is no evidence that azathioprine is teratogenic. There is less experience of ciclosporin in pregnancy but it does not appear to be any more harmful than azathioprine. The use of these drugs during pregnancy needs to be supervised in specialist units. Any risk to the offspring of azathioprine-treated men is small." Nonetheless, patients who are taking any immunosuppressive drug should consult with their physician before conceiving a child, and they should notify the doctor at once when there is any indication of pregnancy.

Basiliximab should not be used during pregnancy. The manufacturer recommends using adequate contraception during use of this drug, and for eight weeks following the final dose.

The manufacturers warn against the use of tacrolimus and mycophenolate during pregnancy, on the basis of findings from animal studies. They recommend using adequate contraception while taking these drugs, and for six weeks after the last dose.

The safety of corticosteroids during pregnancy has not been absolutely determined. There is some evidence that use of these drugs during pregnancy may affect the baby's growth; however, this result is not certain, and may vary with the medication used. Patients taking any steroid drug should consult with their physician before starting a family, and should notify the doctor at once if they think they are pregnant.

Most of these medicines have not been studied in humans during pregnancy. Women who are pregnant or who may become pregnant and who need to take immunosuppressants should consult their physicians.

OTHER MEDICAL CONDITIONS. People with any of the following conditions may have problems if they take immunosuppressant drugs:

People who have shingles (herpes zoster) or chickenpox, or who have recently been exposed to chickenpox, may develop severe disease in other parts of their bodies when they take these medicines. Immunosuppressants may produce more intense side effects in people with kidney disease or liver disease, because their bodies are slow to get rid of the medicine. Oral forms of immunosuppressants may be less effective in people with intestinal problems, because the medicine cannot be absorbed into the body.

Before using immunosuppressants, people with these or other medical problems should make sure their physicians are aware of their conditions.

Side effects

Increased risk of infection is a common side effect of all immunosuppressant drugs. The immune system protects the body from infections; when the immune system is suppressed, infections are more likely. Taking such antibiotics as co-trimoxazole prevents some of these infections. Immunosuppressant drugs are also associated with a slightly increased risk of cancer because the immune system plays a role in protecting the body against some forms of cancer. For example, the long-term use of immunosuppressant drugs carries an increased risk of developing skin cancer as a result of the combination of the drugs and exposure to sunlight.

Other side effects of immunosuppressant drugs are minor and usually go away as the body adjusts to the medicine. These include loss of appetite, nausea or vomiting, increased hair growth, and trembling or shaking of the hands. Medical attention is not necessary unless these side effects continue or cause problems.

The treating physician should be notified immediately if any of the following side effects occur:

unusual tiredness or weakness fever or chills frequent need to urinate

Interactions

The effects of azathioprine may be greater in people who take allopurinol, a medicine used to treat gout. A number of drugs, including female hormones (estrogens), male hormones (androgens), the antifungal drug ketoconazole (Nizoral), the ulcer drug cimetidine (Tagamet), and the erythromycins (used to treat infections), may intensify the effects of cyclosporine. When sirolimus is taken at the same time as cyclosporin, the blood levels of sirolimus may be increased to a level that produces severe side effects. Although these two drugs are usually used together, the dose of sirolimus should be taken four hours after the dose of cyclosporin. Tacrolimus is eliminated through the kidneys. When this drug is used with other medications that may harm the kidneys, such as cyclosporin, the antibiotics gentamicin and amikacin, or the antifungal drug amphotericin B, the blood levels of tacrolimus may rise. Careful kidney monitoring is essential when tacrolimus is given with any drug that might cause kidney damage. The risk of cancer or infection may be greater when immunosuppressant drugs are combined with certain other drugs that also lower the body's ability to fight disease and infection. These drugs include corticosteroids, especially prednisone; the anticancer drugs chlorambucil (Leukeran), cyclophosphamide (Cytoxan), and mercaptopurine (Purinethol); and the monoclonal antibody muromonab-CD3 (Orthoclone), which is also used to prevent transplanted organ rejection.

Not every drug that may interact with immunosuppressant drugs is listed here. Anyone who takes immunosuppressant drugs should give their doctor a list of all other medicines that he or she is taking and should ask whether there are any potential interactions that might interfere with treatment.

by Nancy Ross-Flanigan, Samuel Uretsky

Congress Should Just Say No to Drug Price Controls

Your Inside Report From Capitol Hill

"It" you put the federal government in charge of the Sahara Desert," Nobel economist Milton Friedman once quipped, "in five years there'd be a shortage of sand." Friedman's admonition is especially pertinent to the ongoing effort by Senate liberals to give federal bureaucrats a leading role in setting the price of drugs for seniors.

Their track record on this front, not surprisingly, is appalling.

Two years ago. Senate liberals, led by Majority Whip Dick Durbin (D.-I11.), sought to head off implementation of the new federal drug entitlement for seniors (not a bad idea, given that it's available to even the wealthiest seniors and adds trillions of dollars to our long-term debt). But they did this for the wrong reasons and pursued the wrong remedy.

Heavy-Handed Role

Durbin has bemoaned the absence of a heavy regulatory role for Uncle Sam. Left to negotiate freely, insurers that offer drug coverage under Medicare, he feared, would conspire with drug manufacturers to gouge seniors, and send the cost of prescription drugs under the program "through the roof."

The best way to contain those costs, Durbin argued, was a price control-mandating the price insurers could charge seniors for certain Medicare drug plans. He recently pushed legislation that would have instructed the secretary of the Department of Health and Human Services "to set a uniform national premium of $35 for the first year" and "to negotiate group-purchasing agreements" on behalf of seniors.

Happily, Durbin's legislation went nowhere. He and his colleagues quietly dropped the $35 price control on premiums. Last week, 41 Senate Republicans defeated a procedural motion to stifle debate and floor amendments on this bill, disappointing a coalition of 47 Democrats, Socialist Bernie Sanders (Vt.), six moderate Republicans, and Independent Joe lieberman (Conn.).

Raining on the liberals' parade is the fact that the competitive features of the new drug law have exceeded everyone's expectations. At $22 per month, the average premium for plans this year is more than 40% below the projected monthly cost of $37 and is actually lower than the average cost last year. To taxpayers, this translates into annual savings of $ 13 billion this year and has caused government bean counters to lower projected Medicare costs by $ 189 billion over the next decade. Satisfaction levels among seniors who have these plans, meanwhile, top 80%.

Now Durbin and his colleagues are pushing the second part of his legislation (requiring bureaucrats to interfere in negotiations between insurers and drug manufacturers). They justify the heavyhanded government role they covet by citing the drug program run by the Department of Veterans' Affairs. According to Sen. Daniel Akaka (D.-Hawaii), who chairs the Veterans' Affairs Committee, veterans get "better pharmaceutical care" than those in private or public hospitals, have access to more drugs than Medicare beneficiaries, and register higher levels of satisfaction than patients in the private health-care sector.

Not so. A comprehensive review of the drugs available to veterans by The Lewin Group, a highly respected firm that analyzes the health industry, found that the VA's drug formulary actually bars coverage for 106 of the 300 most widely prescribed drugs to seniors, including 30 of the 100 most widely used. The VA formulary also excludes many new and innovative drugs. According to a study by Columbia University Professor Frank Lichtenberg, the VA list includes only 19% of the drugs approved by the Food and Drug Administration since 2000.

Among the drugs not available: Lipitor (the most prescribed drug to seniors, rated the "best" anti-cholesterol drug by Consumer Reports), Verapamil SR (rated "best" by Consumer Reports to treat high blood pressure), and other widely prescribed drugs for conditions such as acid reflux (Nexium), enlarged prostates (FIomax), arthritis (Celebrex), osteoporosis (Evista) and bladder control (Detrol LA). The list of the 1OO most widely prescribed drugs missing from the VA formulary also includes four each to treat blood pressure, diabetes and cholesterol. Little wonder that one million veterans have voted against the VA's restricted formulary with their dollars, signing up with one of the Medicare drug plans.

This push for more government regulation recalls another prescient observation by Milton Friedman. "Many people want the government to protect the consumer," the great Nobel laureate observed, "A much more urgent problem is to protect the consumer from the government."

Mr. Franc, who has held a number of positions on Capitol Hill, is vice president of government relations at the Heritage Foundation. To send a question or comment, e-mail:

MichaelFranc@heritage.org

Copyright Human Events Publishing, Inc. Apr 23, 2007
Provided by ProQuest Information and Learning Company. All rights Reserved
by Franc, Mike

Viagra shows potential as a cardiopulmonary drug: vasodilatory effects improve heart and lung function by increasing circulation and relaxing blood ve

Sildenafil (Viagra), the much-joked-about drug for erectile dysfunction (ED), is showing serious promise as an effective treatment for a variety of heart, lung and circulatory diseases. Viagra dilates blood vessels throughout the body, mildly decreasing blood pressure, effectively increasing circulation and protecting the heart and lungs from negative reactions to stress.

Physicians continue to be surprised by a growing list of benefits for patients with such complex, difficult-to-treat illnesses as heart failure, pulmonary hypertension and chronic obstructive lung disease (COPD).

HOW AND WHY VIAGRA WORKS

Viagra blocks an enzyme known as phosphodiesterase 5 (PDE5A). This action causes levels of cyclic guanosine monophosphate (cGMP) to rise inside the smooth muscle cells lining veins and arteries. cGMP plays a central role in relaxing blood vessels; an increase in cGMP causes blood vessels to dilate (open).

Interestingly, Viagra was developed to be a cardiac drug, and its ability to cause erections was an incidental finding. Because Viagra proved to have only modest blood pressure lowering effects, it was not expected to have any significant effect on the heart. Experience has proven this theory wrong, and the millions of men who use Viagra for ED have helped bring its cardiopulmonary benefits to light. Following are some key findings of sildenafil (called Revatio for indications other than ED).

GIVING OOMPH TO FAILING HEARTS

Sildenafil increases nitric oxide uptake, which is known to benefit patients with heart failure. Physicians in Australia wondered if this might improve left ventricular function (LV) in weakened hearts. In a double-blind, crossover study, 20 patients with ejection fractions less than 35 percent were given sildenafil or placebo, and their heart failure medications were withheld for at least 12 hours. The drug each patient received was then switched. A variety of tests showed that sildenafil improved the heart's performance by decreasing LV load through several mechanisms. "This can explain the increase in cardiac output and in exercise capacity with sildenafil in patients with heart failure," said the authors in a recent edition of the American Journal of Cardiology.

BLUNTING THE EFFECTS OF STRESS ON THE HEART

One role of cGMP is to help prevent the heart muscle from growing large and weak in response to stress--a condition called cardiac hypertrophy, which can lead to heart failure. Researchers at Johns Hopkins University questioned if sildenafil's ability to increase levels of cGMP could suppress damage caused by this kind of stress. For the study, they recruited 35 healthy volunteers. The volunteers were given multiple tests to determine how their hearts responded to stimulation by dobutamine, a drug that increases heart rate, before and after receiving sildenafil or placebo. Sildenafil prevented damage from occurring during this drug-induced stress without affecting the heart at rest. This study, reported in a recent issue of Circulation, underscored the importance of earlier studies showing the same beneficial effect on hearts stressed by high blood pressure which appeared in Nature Medicine early last year.

LOWERING PULMONARY HYPERTENSION

Many diseases of the heart, lungs and connective tissues, including emphysema and chronic bronchitis, can cause blood pressure to rise in the main artery leading from the heart to the lungs. Symptoms include severe breathlessness and chest pain. This dangerous condition known as pulmonary hypertension is difficult to treat. In a double-blind study, European physicians gave various doses of sildenafil or placebo for 12 weeks to 278 patients with pulmonary hypertension. At the end of this period, patients who took sildenafil were able to walk about 50 yards farther than those who took placebo. The 222 who continued on sildenafil for one year saw a significant drop in pulmonary arterial pressures and continued improvement in their ability to exercise, regardless of the dose of sildenafil they had been taking, according to an article in a recent issue of the New England Journal of Medicine.

In another study, which appeared in a recent issue of Cerebrovascular Disease, of 11 patients with severe pulmonary hypertension, sildenafil was found to improve blood flow to the brain by relaxing its veins and arteries.

ARE ALL ED DRUGS EQUALLY BENEFICIAL?

This question has not been answered. There are two other medications in the same class as Viagra: tadalafil (Cialis) and vardenafil (Levitra). They also cause erections by acting on intracellular cGMP to dilate blood vessels. All three medications can cause side effects in some patients. While some side effects are not serious and stop when the medication wears off, these medications have been known to cause serious side effects, including sudden and permanent loss of vision, fainting and chest pain. Also, these drugs cannnot be combined with certain prescription or over-the-counter medications or herbal supplements, and should not be taken by patients with certain medical conditions.

Of the three ED drugs, only Viagra's effects on the cardiopulmonary system have been studied extensively to date. Many clinical trials are now underway to further define its effects on the conditions mentioned above, as well as on Raynaud's syndrome, scleroderma and other complex diseases. In the future, it appears that Viagra/Revatio may be just what the doctor orders for patients with a wide variety of serious conditions.

DOCTOR'S PERSPECTIVE

WAIT FOR RESULTS OF MORE TRIALS BEFORE WIDESPREAD USE GARY FRANCIS, MD, Head, Section of Cardiology, Cleveland Clinic, Cleveland, OH

"Viagra and other similar drugs are now widely used to treat erectile dysfunction. Their mechanism of action is similar in that they are phosphodiesterase-5 inhibitors. This inhibition leads to smooth muscle relaxation and vasodilation. We have known for years that such drugs may have more selective vasodilator properties on the pulmonary artery tree than on the systemic circuit. The authors have demonstrated that sildenafil (Viagra) improves the heart's performance by diminishing peripheral vascular resistance. There have been numerous studies indicating that oral phosphodiesterase inhibitors may be effective in patients with pulmonary hypertension from a variety of causes, including primary pulmonary hypertension. The improvement in pulmonary artery pressure is translated into improved clinical outcomes, such as less shortness of breath and the ability to do more physical activity. Clearly, such drugs are an option for patients with primary pulmonary hypertension where the development of new therapies has been slow to evolve until the last 5-10 years. It appears to be safe, is less cumbersome than the use of intravenous prostaglandins, and is less expensive than other oral agents that also lower pulmonary vascular resistance. It is unclear whether all phosphodiesterase inhibitor therapies have the same effects in these patients. To date, Viagra has been the most widely studied. Based on the results of these studies, it seems likely that phosphodiesterase inhibitors given in oral form will continue to be studied in patients with peripheral vasospastic diseases including Raynaud's syndrome and scleroderma. However, it would be prudent to wait for the results of randomized controlled trials before embarking on the widespread use of such agents in patients with complex disorders such as this.


COPYRIGHT 2006 Belvoir Media Group, LLC
COPYRIGHT 2007 Gale Group
Health News

Saturday, May 19, 2007

New use for Plavix

The FDA has approved the use of Plavix (clopidogrel) for people who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI), and who are not going to have coronary artery repair (angioplasty).

A STEMI is a severe heart attack caused by the sudden, total blockage of an artery. Each year, an estimated 500,000 Americans have a STEMI heart attack, according to the American Heart Association. In STEMI patients, Plavix prevents subsequent blockage in the already-damaged heart vessel, which could lead to more heart attacks, stroke, and possibly death.

The FDA approved Plavix in November 1997 to decrease platelet function in people who suffer from acute coronary syndrome. Platelets are sticky blood cells that help form a clot, and can contribute to blocked coronary arteries.

Two studies support the effectiveness of Plavix in treating STEMI heart attack patients. A large trial, the Clopidogrel and Metoprolol in Myocardial Infarction Trial (COMMIT) study, demonstrated that Plavix--when combined with other standard treatments including thrombolysis, a procedure to dissolve clots--reduced mortality and also reduced the combined number of recurrent heart attacks, strokes, and deaths. COMMIT was a randomized, double-blind, placebo-controlled trial of 46,000 patients conducted in China.


The findings in COMMIT are supported by results of the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) study. CLARITY was a clinical trial of 3,500 patients undergoing thrombolysis for STEMI heart attacks. CLARITY showed that the coronary artery blood flow was better with clopidogrel treatment compared with placebo.

Serious side effects of Plavix include bleeding and, rarely, low white blood cell counts or low platelet counts with spontaneous bleeding and clotting (thrombotic thrombocytopenic purpura).

Plavix is manufactured by Sanofi Aventis of Bridgewater, N.J.

COPYRIGHT 2006 U.S. Government Printing Office
COPYRIGHT 2006 Gale Group
FDA Consumer

SKB sells Kytril to Roche; Famvir, Vectavir/Denavir to Novartis

SmithKline Beecham has signed two agreements for the divestitures of Kytril, SKB's antiemetic drug for chemotherapy, radiotherapy and post-operative associated nausea and vomiting, and the antivirals Famvir and Vectavir/Denavir. The divestitures are being undertaken to secure regulatory approval for SKB's merger with Glaxo Wellcome, which markets the antiemetic Zofran for chemotherapy and the antivirals Zovirax and Valtrex.

SKB and Roche have signed an agreement for Roche to acquire global rights to Kytril for $1.23 billion in cash. At the same time, SKB will pay Roche $400 million in cash for exclusive U.S. and Canadian rights for Coreg, the drug for congestive heart failure. SKB is currently in a co-promotion agreement with Roche to market Coreg in the United States. In 1999, U.S. sales of Coreg were $196 million.

In a separate agreement, Novartis will acquire global rights to the antivirals Famvir, indicated for the treatment of acute herpes zoster and herpes simplex, and Vectavir/Denavir, for the treatment of herpes labialis, from SKB for $1.63 billion in cash.


COPYRIGHT 2000 Lebhar-Friedman, Inc.
COPYRIGHT 2000 Gale Group
Drug Store News

for osteoporosis prevention - Prempro, Premphase, Premarin

Wyeth Pharmaceuticals has updated the package inserts for its postmenopausal hormone drugs Prempro, Premphase, and Premarin to urge physicians who prescribe those drugs solely for the prevention of postmenopausal osteoporosis to carefully consider alternative therapies.

In addition to including this new recommendation, the updated inserts also state more prominently that the products are not intended to treat or prevent coronary heart disease, that they should be used for the shortest time possible consistent with individual patient treatment goals and risks, and that all patients taking these drugs should be regularly reevaluated.

"This information was already included on the insert, but we made it more obvious," said Dr. Victoria Kusiak, North American medical director for Wyeth Pharmaceuticals, Philadelphia.

The insert update follows this summer's announcement by the National Institutes of Health that it was discontinuing the combination hormone replacement therapy arm of the Women's Health Initiative (WHI), a large, multicenter trial involving thousands of women, after those taking Wyeth's drug Prempro were found to have an increased risk of invasive breast cancer, coronary heart disease, stroke, and pulmonary embolism.


Wyeth's updated package inserts will also include the WHI findings. The company has also sent letters to physicians informing them of the update.

As soon as Wyeth learned of the WHI findings, company officials contacted the Food and Drug Administration and other regulatory agencies worldwide about the company's intention to revise the packaging. Discussion with the FDA followed, Dr. Kusiak said, but the agency said it wouldn't be able to approve the labeling change until after its advisory committee meeting, tentatively set for late October or early November, and until it had reviewed more information from the WHI database.

"We decided that in the interest of patient health and getting the information out to physicians we couldn't wait that long," Dr. Kusiak said. "We went ahead and made the decision to update based on the data that we did have."

Dr. Kusiak said Wyeth wasn't pleased about revising recommendations based on the data in one journal article, but despite Wyeth's requests, including a Freedom of Information Act request, the National Institutes of Health has refused to release the WHI database.

"Their answer is that they have 27 papers yet to be published from the database and that we cannot have access to it until those have been published," Dr. Kusiak said. "We are negotiating with them to try and gain access earlier."

Diane Striar, senior press liaison for the National Heart, Lung, and Blood Institute, confirmed that NIH is processing a Freedom of Information Act request from Wyeth but couldn't comment on why the agency has refused to release the WHI database to the pharmaceutical company.

Wyeth has also submitted to NIH a list of specific questions about the WHI data in the hopes of getting at least some additional information. There has not yet been a response to that request, Dr. Kusiak said. Since the WHI was a government-funded study, NIH is required to release the information within 3 years.

Wyeth's new recommendations will further complicate decisions about instituting or continuing hormone replacement therapy especially in the area of osteoporosis prevention, predicted Dr. Wulf Utian, executive director of the North American Menopause Society, Cleveland.

"There is now an open question for which I don't see any answers in the medical literature," he said: How safe is it to administer other osteoporosis prevention drugs for prolonged periods?

"The median age for perimenopause is 51" he said. "And there are many women even younger who are faced with premature ovarian failure" or other conditions that cause early menopause. I think the dilemma we will face is, would you give a bisphosphonate to a young woman for a period in excess of 10-20 years? And what would be the likely outcome?"

COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2002 Gale Group
by Michele G. Sullivan

Effexor XR is fastest-growing therapy option in the antidepressant market

Wyeth Pharmaceuticals, citing data from IMS Health, reported last month that its dual-action antidepressant Effexor XR (venlafaxine HCl) has become the fastest-growing therapy option in the antidepressant market. That market is valued at $13 billion annually. In addition to depression, Effexor XR, a serotonin/norepinephrine reuptake inhibitor is indicated for the treatment of generalized anxiety disorder. It is thought to work by increasing the levels in the brain of serotonin and norepinephrine.

COPYRIGHT 2002 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2002 Gale Group
Drug Store News

FDA warns of Zyprexa® and Zyrtec® substitution errors

Reports of medication dispensing or prescribing errors involving Zyprexa (olanzapine; Eli Lilly & Co.) and Zyrtec (ceterizine HCl; Pfizer, Inc.) have led to an official FDA warning to healthcare professionals according to an alert from MedWatch the FDA's safety information and adverse event reporting program. Errors included instances of olanzapine substitution for ceterizine HCl and vice versa. Substitutions have been likely due to similarities in brand name, available dose strengths, and dosing interval.

Ceterizine HCl is a nonsedating antihistamine indicated for the treatment of chronic urticaria and allergic rhinitis. Olanzapine is an atypical antipsychotic agent used for the treatment of bipolar affective disorder and schizophrenia. Medication substitutions of these two drugs could lead to potential relapse in patients with psychiatric disease and other adverse events.

Lilly & Co. has changed the package labeling on bottles of olanzapine from ZYPREXA to ZyPREXA in an attempt to minimize potential dispensing errors. In addition, the company has launched an awareness campaign to draw attention to this problem. It is recommended that prescribers include brand and generic names on written prescriptions.

COPYRIGHT 2005 Journal of Drugs in Dermatology, Inc.
COPYRIGHT 2005 Gale Group
Journal of Drugs in Dermatology

Clinical quiz

Clinical Quiz questions are based on selected articles in this issue of American Family Physician. Answers appear in this issue. AFP has been reviewed by the American Academy of Family Physicians as having content acceptable for Prescribed credit. Term of approval is for one year from the beginning distribution date of January 2005. This issue has been reviewed and is acceptable for up to 5.0 Prescribed credits, of which 0.75 credit conforms to AAFP criteria for evidence-based continuing medical education (EB CME) clinical content. The amount of CME has been doubled to reflect two-for-one credit for the EB CME portion only. When reporting CME credits, AAFP members should report total Prescribed credits earned for this activity. It is not necessary for members to label credits as EB CME for reporting purposes.

The AAFP is accredited by the Accreditation Council for Continuing Medical Education to provide CME for physicians.

The AAFP designates this educational activity for a maximum of 5.0 Category 1 credits toward the American Medical Association Recognition Award (AMA/PRA). Each physician should claim only those credits that he or she actually spent in the activity.

AAFP Credit

Each copy of AFP contains a Clinical Quiz answer card. AAFP members may use this card to obtain the designated number of Prescribed credit hours for the year in which the card is postmarked.

AMA/PRA Category 1 Credit

AAFP members who satisfy the Academy's CME requirements are automatically eligible for the AMA/PRA.

Physicians who are not members of the AAFP are eligible to receive the designated number of credits in Category 1 of the AMA/PRA on completion and return of the Clinical Quiz answer card. AFP keeps a record of AMA/PRA Category 1 credits for nonmember physicians. This record will be provided on request; however, nonmembers are responsible for reporting their own Category 1 CME credits when applying for the AMA/PRA or other certificates or credentials.

For health care professionals who are not physicians and are AFP subscribers, a record of CME credit is kept by the AAFP and will be provided to you on written request. You are responsible for reporting CME credits to your professional organization.

NOTE: The full text of AFP is available online (http://www.aafp.org/afp), including each issue's issue will link you to the Clinical Quiz. Just follow the online directions to take the quiz and, if you are an AAFP member, you can submit your answers for CME credit.

Instructions

(1) Read each article, answer all questions on the quiz pages, and transfer your answers to the Clinical Quiz answer card (bound into your copy of AFP). This will help you avoid errors and permit you to check your answers against the correct answers.

(2) Mail the Clinical Quiz answer card within one year (by November 30, 2006). The bar code on the answer card contains your identification for CME credit hours.

Before beginning the test, please note: Each Clinical Quiz includes two types of questions: Type A and Type X.

Type A questions have only one correct answer and may have four or five choices. Here is a typical Type A question:
Q1. Most allergic reactions
to foods are:

[] A. Due to IgA deficiency.
[] B. Due to IgG and IgM
antibodies.
[check] C. IgE-mediated.
[] D. Due to enzyme
deficiencies.
[] E. Due to toxins.

Type X questions may have one or more correct answers. They are multiple true-false questions with four options. Here is a typical Type X question:
Q2. Causes of varicosities in
pregnancy include:

[check] A. Hormonal changes.
[check] B. Venous compression.
[check] C. Familial tendency.
[check] D. Prolonged sitting and standing.

Clinical Quiz questions are written by the associate and assistant editors of AFP.

Type A Questions

Each question has only one correct answer.

Articles

Diagnosis and Management of Ectopic Pregnancy
(p. 1707)

Q1. Approximately what percentage of women have difficulty
conceiving after treatment of an ectopic pregnancy?

[] A. 10.
[] B. 30.
[] C. 50.
[] D. 70.

Q2. Which one of the following is the most cost-effective
approach to evaluating patients with suspected ectopic
pregnancy?

[] A. Quantitative beta subunit of human chorionic
gonadotropin (beta-hCG) alone.
[] B. Urgent laparoscopy.
[] C. Transvaginal ultrasonography alone.
[] D. Transvaginal ultrasonography followed by
quantitative beta-hCG.

Detection and Evaluation of Chronic Kidney Disease
(p. 1723)

Q3. Which one of the following statements about imaging
options in chronic kidney disease is correct?

[] A. Computed tomography is the most effective for
diagnosing renovascular disease.
[] B. Intravenous pyelography is commonly used in
patients with chronic kidney disease.
[] C. Plain-film radiographs of the kidneys, ureters,
and bladder are used to screen for polycystic
kidney disease.
[] D. Radioisotope renal scanning can monitor
individual kidney function.

Management of Acute Renal Failure (p. 1739)

Q4. Which one of the following statements about the use of
dopamine to promote renal perfusion in patients with acute
renal failure is correct?

[] A. Dopamine reduces morbidity.
[] B. Dopamine reduces mortality.
[] C. Dopamine has no benefit.
[] D. Dopamine reduces the need for dialysis.
[] E. Dopamine reduces the length of intensive care
unit stays.

Q5. Which one of the following is the most common prerenal
cause of acute renal failure?

[] A. Intravascular volume depletion.
[] B. Nephrotic syndrome.
[] C. Nonsteroidal anti-inflammatory drugs.
[] D. Angiotensin-converting enzyme inhibitors.
[] E. Congestive heart failure.

A Clinical Approach to Diagnosing Wrist Pain (p. 1753)

Q6. Which one of the following statements about the
mechanical causes of wrist pain is correct?

[] A. de Quervain's tenosynovitis is associated with
tenderness at the distal ulna with palpation.
[] B. Nonunion of the hook-of-the-hamate is associated
with tenderness in the proximal hypothenar area
1 cm distal to the flexion crease of the wrist.
[] C. Kienbock's scaphoid bone.
[] D. Triangular fibrocartilage complex tear is identified
by tenderness in the distal hollow between the
scaphoid and ulnar styloid.

Q7. Which one of the following statements about
examination of the wrist is correct?

[] A. Watson's
[] B. Finkelstein's ligament tear.
[] C. Pain, crepitus, or a snap during the grind test
identifies fracture of the hamate.
[] D. The lunotriquetral shear test involves asking the
patient to place his or her palms on the underside of a
table and lift it.

Extrapulmonary Tuberculosis: An Overview (p. 1761)

Q8. Which one of the following statements about tuberculous
lymphadenitis is correct?

[] A. Inguinal adenopathy is the most common.
[] B. Patients without human immunodeficiency virus
(HIV) infection typically present with fever, night
sweats, and weight loss.
[] C. Most patients have an abnormal result on chest
radiography.
[] D. Left untreated, the lymph nodes become fluctuant
and drain spontaneously with sinus tract
formation.
[] E. Fine-needle aspiration is the diagnostic procedure
of choice for patients without HIV infection.

Medications for Treating Alcohol Dependence (p. 1775)

Q9. Which one of the following statements about disulfiram
(Antabuse) is correct?

[] A. It is recommended for patients older than 60 years.
[] B. It decreases the rate of relapse.
[] C. It is the drug of choice for long-term prevention
of relapse.
[] D. Consuming alcohol after taking it can cause a
severe reaction.

Cochrane for Clinicians:
Putting Evidence into Practice EB CME

Psychological Interventions for Noncardiac Chest Pain
(p. 1701)

Q10. Which one of the following statements about treatment
for chronic, nonspecific chest pain in patients with normal
coronary anatomy is correct?

[] A. Cognitive behavior therapy reduces the number of
days with chest pain.
[] B. Comorbid psychiatric symptoms are rare.
[] C. Reassuring the patient that the cause is noncardiac
usually eliminates the symptoms.
[] D. No treatment is needed because functional
impairment is rare.

BMJ: Clinical Evidence Concise EB CME

Chronic Fatigue Syndrome (p. 1793)

Q11. Which one of the following therapies for patients with
chronic fatigue syndrome has been shown to be beneficial in a
controlled trial?

[] A. Corticosteroids.
[] B. Antidepressants.
[] C. Graded aerobic exercise.
[] D. Prolonged rest.

Type X Questions

Each question has one or more correct answers.

Articles

Diagnosis and Management of Ectopic Pregnancy
(p. 1707)

Q12. Which of the following statements about methotrexate
therapy for ectopic pregnancy is/are correct?

[] A. The single-dose regimen is significantly more
effective than the multiple-dose regimen.
[] B. The success rate is higher with lower baseline
levels of beta subunit of human chorionic gonadotropin.
[] C. The overall success rate is 66 percent.
[] D. The single-dose regimen has slightly fewer side
effects compared with the multiple-dose regimen.

Detection and Evaluation of Chronic Kidney Disease
(p. 1723)

Q13. Which of the following statements about diagnostic
evaluation of kidney disease is/are correct?

[] A. Rash and arthritis are clues to the presence of
glomerulonephritis.
[] B. Red blood cell casts are associated with essential
hypertension.
[] C. Dysmorphic red blood cells are associated with
low flow states.
[] D. Red blood cell casts are associated with
glomerulonephritis.

Q14. Which of the following tests is/are recommended by the
Kidney Disease Outcomes Quality Initiative guidelines to
screen for chronic kidney disease?

[] A. Serum creatinine level.
[] B. A 24-hour urine collection for creatinine clearance.
[] C. Estimation of the glomerular filtration rate.
[] D. Microalbumin-sensitive urine dipstick.

Management of Acute Renal Failure (p. 1739)

Q15. A 45-year-old patient has allergic interstitial nephritis.
Which of the following medications can cause this condition?

[] A. Allopurinol (Zyloprim).
[] B. Cephalosporins.
[] C. Furosemide (Lasix).
[] D. Cimetidine (Tagamet).

A Clinical Approach to Diagnosing Wrist Pain (p. 1753)

Q16. Which of the following conditions is/are possible causes
of wrist pain?

[] A. Amyloidosis.
[] B. Carpal tunnel syndrome.
[] C. Osteomyelitis.
[] D. Reflex sympathetic dystrophy (i.e., complex
regional pain syndrome).

Extrapulmonary Tuberculosis: An Overview (p. 1761)

Q17. Limited evidence suggests adjunctive corticosteroids
may be beneficial in patients with which types of extrapulmonary
tuberculosis?

[] A. Tuberculous meningitis.
[] B. Tuberculous pericarditis.
[] C. Miliary tuberculosis with refractory hypoxemia.
[] D. Gastrointestinal tuberculosis.

Medications for Treating Alcohol Dependence (p. 1775)

Q18. Which of the following drugs is/are approved by the
U.S. FDA for the treatment of alcohol disorders?

[] A. Disulfiram (Antabuse).
[] B. Acamprosate (Campral).
[] C. Topiramate (Topamax).
[] D. Naltrexone (Trexan).

Putting Prevention into Practice: An
Evidence-Based Approach EB CME

Screening for Gonorrhea (p. 1799)

Q19. At a routine wellness examination, a pregnant
gonorrhea screening test is positive. Which of the following
actions is/are appropriate?

[] A. Arrange testing or presumptive treatment for the
patient's sexual partner.
[] B. Treat the patient with a third-generation
cephalosporin.
[] C. Consider a second gonorrhea screening test during
the third trimester.
[] D. Delay treatment until the second trimester.

CME Quality Survey

Please answer the following questions to help us monitor the quality of AFP's CME material on an ongoing basis. Mark your answers on this issue's quiz card. We would appreciate hearing any suggestions you have for improving the CME experience offered through AFP. See the directory on page 1635.
Q1. Which of the following articles covered in this quiz
provide information that you find useful? (On the answer
card, please circle all that apply.)

[] A. Diagnosis and Management of Ectopic Pregnancy
(p. 1707).
[] B. Detection and Evaluation of Chronic Kidney
Disease (p. 1723).
[] C. Management of Acute Renal Failure (p. 1739).
[] D. A Clinical Approach to Diagnosing Wrist Pain
(p. 1753).
[] E. Extrapulmonary Tuberculosis: An Overview
(p. 1761).
[] F. Medications for Treating Alcohol Dependence
(p. 1775).
[] G. Psychological Interventions for Noncardiac Chest
Pain (p. 1701).
[] H. Chronic Fatigue Syndrome (p. 1793).
[] I. Screening for Gonorrhea (p. 1799).

Q2. In general, how clear was the presentation of the
information in these articles? (On the answer card, please
circle one number: 5 = extremely clear; 0 = extremely unclear.)

Q3. Thinking of all the issues of AFP that you've seen
recently, please rate the overall quality of AFP as a vehicle
for continuing medical education in the clinical aspects of
practice. (On the answer card, please circle one number: 5 =
excellent; 0 = poor.)

Answers to This Issue's Clinical Quiz

Q1. B Q2. D Q3. D Q4. C Q5. A Q6. B Q7. A Q8. D Q9. D Q10. A Q11. C Q12. B, D Q13. A, D Q14. A, C, D Q15. A, B, C, D Q16. A, B, C, D Q17. A, B, C Q18. A, B, D Q19. A, B, C

COPYRIGHT 2005 American Academy of Family Physicians
COPYRIGHT 2005 Gale Group
American Family Physician