HRT packaging to carry new safety recommendation: consider alternatives before prescribing these agents solely 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," ...