I’m disappointed and you should be too. Today, the Food & Drug Administration announced the approval of flibanserin, a proposed treatment for “hypoactive sexual desire disorder” in women. Since its founding, the National Women’s Health Network has ensured that the voices of women consumers are heard and respected. Today, clever marketing trumped decades worth of consumer protections that the Network has worked hard to secure and maintain.
This past June, I testified at the FDA expressing our concern that flibanserin’s serious side effects, including low blood pressure, dizziness, and fainting, far outweigh the minimal clinical benefit of this drug. I urged the FDA to require additional safety studies assessing flibanserin’s interaction with alcohol and birth control – the sponsor’s 25 person alcohol safety study only included two women! I made sure that women were at the table and that our voices were heard.
In 2010 and 2013 we spoke out about our serious concerns about the safety and efficacy of this drug. The FDA heard us loud and clear and rejected this same drug twice before. Despite the advocacy of the Network and similar women’s health organizations, this time around the advisory committee recommended approval and the FDA listened to them.
The National Women’s Health Network recognizes that a lack of sexual desire can be a distressing problem for women. We also believe that it might be possible to develop a drug that is effective for some of women’s sexual problems. Women also rely on the FDA to make evidence-based decisions regarding drug and medical device applications. Unfortunately, it appears this time the FDA was swayed by a relentless public relations campaign.
Despite the unfavorable outcome of today’s decision, we will continue to monitor this issue and keep you updated as news develops – you can count on us to dig deep into the evidence, and speak up on behalf of women. For more information, press statements, and the latest news on flibanserin, check out the NWHN website. Also, if you have not already done so, connect with us on Twitter and Facebook for live updates.