“Female Viagra” Approved by FDA
Female Viagra Approved by FDA
Yesterday, the FDA approved the first drug to treat low or absent sexual desire in pre-menopausal women. Popularly known as female Viagra, the drug, Addyi, has created a clear divide in feminist circles. On one side of the debate are advocates for the drug. Many of them are part of Even the Score, a coalition that has framed the controversy surrounding the drugwhich has been up for FDA approval a total of three timesas an issue of gender equality. They argue, for instance, that it is unfair that there has not been a treatment for womens low libido, since Viagra and similar drugs for men have been approved for yearsalthough these drugs treat erectile dysfunction, not decreased libido.
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Critics, however, say that the drugs risksincluding low blood pressure, nausea and dizzinessdont outweigh its benefits, which include an increase of no more than one sexually satisfying event per month. (WOW, ONE event per month--BOB works better than that!)
This is a triumph of marketing over science, says Cindy Pearson, executive director of the National Womens Health Network. Women dont have enough information to accurately assess the risk of this drug. She added that the FDAs decision to require post-market studies of the drug is feeble and unreliable since about half of all studies required by the FDA post-approval are never completed.
In June, a governmental advisory committee recommended the FDA approve the drug. Prior to that meeting, the FDA had rejected the drug twice for not meeting risk-to-benefit ratio standards. The drugs manufacturer, Sprout Pharmaceuticals, conducted a safety study after the drug was rejected a second time using mostly male participants (a drug for females, tested on males?? WTF?????); the drug was approved anyway.
http://msmagazine.com/blog/2015/08/19/female-viagra-approved-by-fda/