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