“In the first half of 2006, women in the USA spent nearly $90 million on unapproved estrogen-plus-testosterone pills, says IMS Health, a pharmaceutical information company. Estratest, made by Solvay Pharmaceuticals, represented 75% of the market,” writes Rita Rubin in USA Today.
Would it surprise you to learn that Estratest, a combination of estrogen and testosterone, has never received FDA approval?
Last month, the National Women’s Health Network petitioned the FDA to stop marketing estrogen-and-testosterone combination pills such as Estratest and Syntest (a generic version of the same drug). From the NWHN’s Aug. 28 health alert:
Both products carry a label indicating that they should be used for treatment of moderate to severe vasomotor symptoms, such as hot flashes, that don’t respond to estrogen alone. But the NWHN has filed a citizen’s petition with the FDA demanding that it stop the manufacturers from marketing these products due to lack of evidence of effectiveness and concerns about serious health risks to women.
“This is an outrageous example of drug companies manipulating the FDA regulatory process for their own benefit at the expense of women’s health,” says Cynthia Pearson, NWHN Executive Director. “The FDA determined several years ago that there’s no evidence that combination estrogen/testosterone products are effective for this use, yet Estratest still remains on the market years later.”
[...] The NWHN is not just concerned about the use of a product that hasn’t been proven to work; it also points out that there’s evidence that estrogen/testosterone combinations may pose a serious threat to women’s health. Recent findings from the Nurses’ Health Study show that Estratest significantly increases a woman’s risk for invasive breast cancer.  In addition, there are other serious health risks associated with testosterone use by women, and an FDA advisory committee recommended against approval of a testosterone product for women in 2004 due in part to concerns about the safety of long-term exposure to testosterone.
The NWNH’s citizen petition on Estratest and Syntest is available here (PDF). The footnote cited above refers to a study published in July in the Archives of Internal Medicine: Combined Estrogen and Testosterone Use and Risk of Breast Cancer in Postmenopausal Women.
According to USA Today, Solvay spokesman Neil Hirsch sent an e-mail to the newspaper in which he stated the company “stands behind the safety and efficacy of Estratest brand products. After more than 40 years of patient use and 39-plus million prescriptions written for the product, Estratest continues to serve as an important therapeutic alternative.”
Rubin adds, “Yet, in April 2003, the FDA stated in the Federal Register that it no longer believed there was ‘substantial evidence’ of the hormone combination’s effectiveness. The FDA invited manufacturers to ask for a hearing if they disagreed. Solvay and Breckenridge, maker of Syntest, quickly did so. The hearing has yet to be held, so the makers can keep selling their products.”