Use of unapproved drugs in the U.S.

Sep 20 2006

USA Today on Monday looked at the use of unapproved drugs in the U.S., including some that are used to treat menopause symptoms (Rubin, USA Today, 9/18).

FDA in 2003 launched a formal inquiry into Solvay's Estratest, an estrogen-testosterone combination therapy used to treat menopause-associated hot flashes, and Breckenridge Pharmaceuticals' Syntest, an estrogen-testosterone combination therapy, because of doubts about their efficacy. The National Women's Health Network last month petitioned FDA to stop sales of the drugs until they are proven safe and effective.

Agency spokesperson Susan Cruzan has said that Solvay and Breckenridge had requested hearings of the treatments and that the agency was reviewing their requests.

Solvay spokesperson Neil Hirsch has said Estratest is a safe and effective alternative for treating menopausal symptoms and that the company has been conducting clinical trials of estrogen-testosterone combinations (Kaiser Daily Women's Health Policy Report, 8/24).

According to USA Today, some consumer groups affiliated with Community Catalyst's Prescription Access Litigation Project in 2003 filed a lawsuit in California Superior Court in Los Angeles that aims to halt "false and misleading advertising related to the marketing and sale" of Estratest.

According to IMS Health, a pharmaceutical information company, women residing in the U.S. spent nearly $90 million on unapproved estrogen-testosterone therapies in the first half of 2006, and Estratest represented 75% of such sales (USA Today, 9/18).