Estrogen/androgen combo questioned for hot flashes: FDA; 'substantial evidence is lacking' that the combo works in estrogen nonresponders. (Company Defends its Products).

The Food and Drug Administration has begun a formal process to evaluate the efficacy of two estrogen / androgen combinations currently marketed for the treatment of moderate to severe menopausal hot flashes in women who don't respond to estrogen alone.

"FDA believes that substantial evidence is lacking that the addition of an androgen can improve the effectiveness of estrogen alone in the treatment of vasomotor symptoms," the agency reported last month (Federal Register 68[711:17953-57, April 14, 2003).

In a Talk Paper released by the FDA, the agency noted that "questions about the net benefits of estrogen / androgen combination products require resolution if the long-term availability of such products is to be supported for any use."

The two products that are affected by these proceedings are Estratest and Estratest H.S., both marketed by Solvay Pharmaceuticals Inc.

The two products can remain on the market while the FDA is conducting the proceedings, the agency said.

Estratest has been on the U.S. market for 38 years, and more than 34 million prescriptions have been written for it, according to Solvay. Estratest tablets contain 1.25 mg of esterified estrogens and 2.5 mg of methyltestosterone. Estratest H.S. tablets contain half those dosages.

Although the products are marketed solely for the management of vasomotor symptoms, many physicians prescribe them off label for the treatment of sexual dysfunction, according to Dr. Wulf Utian, executive director of the North American Menopause Society.