2003 Safety Alert - Prempro / Premphase / Premarin
Safety Alert from Wyeth Pharmaceuticals
This is the text of a letter from Wyeth Pharmaceuticals. Contact the company for a copy of any referenced enclosures.
January 6, 2003
Dear Health Care Professional:
We are writing to inform you that Wyeth, in close cooperation with the U.S. Food and Drug Administration
(FDA), has adopted new labeling for Prempro™ (conjugated estrogens/medroxyprogesterone acetate tablets), Premphase® (conjugated estrogens/medroxyprogesterone acetate tablets), and Premarin®
(conjugated estrogens tablets, USP). A copy of the new Prescribing Information is enclosed and is available at www.premarin.com and www.prempro.com.
The labeling changes include a boxed warning, which states that estrogens and estrogens plus progestin therapies should not be used for the prevention of cardiovascular disease. The boxed warning for estrogen-only therapies includes this same language as well as the long-recognized advisory that estrogens increase the risk of endometrial cancer when used without a progestin.
The boxed warning also includes risk information that previously appeared in other sections of the labeling. Specifically, it states that because the
