Pharmaceutical

FDA advisors raise concerns over ‘female Viagra’ during third review

viagra FDA advisors raise concerns over female Viagra during third reviewThe Food and Drug Administration (FDA), for the third time, is raising concerns about safety risks with the so-called female Viagra drug currently under review. The agency says the drug can cause women to faint and accidentally injure themselves, especially if the medication is taken with alcohol.

The concerns were published on the FDA’s website two days before an FDA advisory panel will decide whether to recommend approval of the drug or, for the third time, reject it based on concerns. The FDA is not required to follow the recommendations of its advisory panels, but it usually does.

The drug filbanserin, which would be marketed as Addyi, was developed by Sprout Pharmaceuticals. It is designed for premenopausal women whose lack of sexual desire causes distress. Clinical studies on the effectiveness of the drug found that women who took the drug had a significant improvement in the number of “satisfying sexual events” along with a reduction of distress related to low desire. Increased desire was seen on a monthly scale rather than a daily one.

FDA advisors have rejected filbanserin twice before saying the benefits of the drug did not outweigh the side effects, which include nausea, dizziness and sleepiness, along with fainting.

Drug maker Boehringer Ingelheim developed filbanserin, a selective serotonin reuptake inhibitor (SSRI), to treat depression but found it to be ineffective in that role. In 2010, the company sought FDA approval for the drug as a female version of Viagra. Regulators rejected the application, saying the benefits did not outweigh the risks.

Boehringer sold the drug to Sprout, which conducted additional studies for the new indication and in 2013, resubmitted the application to the FDA. Once again, the FDA rejected the drug.

Filbanserin’s challenges winning FDA approval have set some women’s groups ablaze, questioning whether there is a double standard and gender bias among drug regulators. Nearly two dozen medications have been approved to treat erectile dysfunction or boost libido through testosterone supplements. No medications have been FDA approved to treat female sexual dysfunction.

Sources:
Reuters
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