A Food and Drug Administration panel voted 18-6 to recommend approving Flibanserin, a drug to help women with low sexual desire. The FDA had rejected the drug twice before, saying the side effects outweighed its benefits.
Those side effects include sleepiness, a drop in blood pressure,
and fainting. These effects are increased when the drug is
combined with alcohol. On two previous occasions, the FDA had
said the drug – often referred to as a “female Viagra” –
had a “challenging benefit/risk assessment.”
The committee on Thursday described the drug’s benefit as
“moderate” or “marginal.”
Flibanserin was first created to combat depression, which it
wasn’t very good at doing. While being dubbed the “female
Viagra,” it has little in common with the famous blue pill
that sustains erections in men for several hours by increasing
blood flow to the genitalia. Unlike Viagra, which is taken when
desired, Flibanserin has to be taken every day whether a woman
wants sex or not. It works on neurotransmitters in the brain,
affecting receptors that react to chemicals such as serotonin and
dopamine, thus increasing sexual desire in some women.
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The drug’s developer, Sprout Pharmaceuticals, conducted a series
of double-blind trials lasting 24 weeks in which 40-60 percent of
the women participating benefited from the treatment. The
committee found that, after adjusting the data to
account for the placebo effect, the drug wound up helping only
about 10 percent, with frequency of sexual desire increasing from
two to three times a month to four times a month.
The panel’s other concern was Flibanserin’s interaction with
other drugs like birth control pills. Some members were worried
about a two-year cancer study that found mice given four times
the daily 100 milligram dose experienced an increased risk of
developing breast cancer tumors. The Washington Post reported “one advisory panel called the
potential link to cancer a ‘show stopper,’ especially as the
double-blind trials only lasted from one year to 18 months.”
Sprout Pharmaceuticals enlisted a number of women’s groups in a
campaign to promote the drug as a feminist issue, pointing out
that men have drugs like Viagra, but that nothing similar exists
for women.
One supporter of the
drug is Sally Greenberg, executive director of the National
Consumers League, who said loss of libido is very destructive to
women’s relationships, their families, and their
self-image.
“We know this is a problem with their
brain chemistry. Just like depression. And, just like depression,
their brain chemistry can be adjusted. We can treat it. And we
should treat it,”
Greenberg told The Washington Post.
“I think this is a huge
moment for women’s sexual health, in the way that the pill was
for women’s sexual health and ability to control their own
destiny,” she
said.
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