An FDA advisory committee voted to recommend approval of flibanserin, which would become the first drug to treat low libido in women (in anyone, for that matter—Viagra treats erectile dysfunction, not libido).
The committee voted 18-6 to approve the pill. According to the New York Times, it’s meant to be taken daily and, over time, influences levels of dopamine and seratonin in the brain. It would be “for women whose lack of sexual desire was not attributable to other causes such as disease or relationship troubles, providing that certain steps were taken to limit the risks of the drug.”
Doctors might be required, for instance, to inform patients of potential side effects — like low blood pressure, fainting, nausea and dizziness — and physicians might have to become certified to prescribe the drug.
Side effects apparently worsen when the drug is taken with alcohol, or alongside other prescription medications.
According to the Times article, the Food and Drug Administration generally follows the lead of its advisory committee, meaning the drug could be formally approved by August 18th. However, the road to approval has been rocky—some groups have alleged that the reason behind the long delay (flibanserin has been rejected twice by the FDA since 2010) is sexism, plain and simple.
Others are unimpressed with the drug’s performance. The Times quoted Dr. Adriane Fugh-Berman of Georgetown University and PharmedOut, who called flibanserin “a mediocre aphrodisiac with scary side effects.” According to Dr. Fugh-Berman, the company is riding the gender equality tide in order to sneak in a basically ineffective drug:
“To approve this drug will set the worst kind of precedent — that companies that spend enough money can force the F.D.A. to approve useless or dangerous drugs.”
However, the Times makes a valuable point, attributed to proponents of the drug: if flibanserin is not approved, it will send a signal to the pharmaceutical industry that treatments for female sexual dysfunction are not worth pursuing.
We’ve gotta start somewhere, right?
Image via Associated Press.
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