The National Women's Health Network has petitioned FDA to stop sales of Solvay's Estratest and Breckenridge Pharmaceuticals' Syntest, which are estrogen-testosterone combination therapies used to treat menopause-associated hot flashes, until they are proven safe and effective, Reuters reports.
"Despite a lack of efficacy for the labeled (use), Solvay and Breckenridge continue to circumvent the FDA regulatory process and market these products," the petition says.
The petition also says that both hormones when used alone carry risks -- including stroke, heart attack, breast cancer, liver damage and fluid retention that can lead to high blood pressure or heart failure.
FDA in 2003 launched a formal inquiry into the drugs because of doubts about their efficacy.
FDA spokesperson Susan Cruzan said that Solvay and Breckenridge had requested hearings of the treatments and that the agency was reviewing their requests.
Solvay spokesperson Neil Hirsch said Estratest is a safe and effective alternative for treating menopausal symptoms.
He also said that a National Academy of Sciences review in the 1970s found combinations of estrogen and androgen -- which is in the same hormone class as testosterone -- are effective alternatives for women who experience moderate to severe hot flashes and do not benefit from estrogen-only therapies.
Solvay also has been conducting clinical trials of estrogen-testosterone combinations, Hirsch said, adding, "We will work with the (FDA) to ensure the continued availability of the product for the women who benefit from it." Breckenridge President Larry Runsdorf said the company would review the petition and release a response.