On Thursday, the U.S. Food and Drug Administration has finally given the green light to a controversial pink pill designed to improve sex life of women with low sexual desire after rejecting it twice in five years.
Flibanserin, nicknamed “female viagra,” was approved on an 18-6 vote by a panel of advisers who cautioned that the drug should be improved in order to have its side-effects reduced. In August, the FDA is set to reach its final decision on the issue.
But critics of the pill said that female sexuality is far more complex than the male’s so trying to “fix” it with a pill may not be the case. Moreover, flibanserin has too many side-effects to receive a final approval from the FDA.
But Sprout Pharmaceuticals, the pill’s producer, claims that its drug may turn into a “societal breakthrough for women” unless the FDA rejects it once more. The company also criticized the federal agency for overlooking female-oriented therapies, while authorizing a series of drugs designed to improve the sexual life of males.
Dr. Lori Brotto, a sexual health researcher at the University of British Columbia, believes that the drug could only benefit some women because of the “oversimplification” of the female sexual arousal mechanism and the various side-effects.
The pink pill, which was designed to treat hypoactive sexual desire disorder in premenopausal women, would be taken before bedtime on a daily basis. The disorder affects seven percent of women.
But the FDA declined to approve flibanserin twice because its drawbacks off-set the benefits. In 2010, the panel of advisers rejected the drug on a unanimous vote.
In 2013, the drug was rejected again, but Sprout organized a campaign to pressure the agency into approving the drug. Back then, organizers accused the FDA that it discriminated against women because it approved drugs to improve men’s sex life but left women with no options.
But feminist groups said the company was using women’s rights as a cover to receive approval for a drug that had little to no benefits.
However, the company’s clinical trials showed that the drug worked better than a placebo. For instance, women who took the pill said that in a month their “sexually satisfying events” rose by about one event more than for their peers that were “treated” with a placebo. Still, the difference in the improvement of sexual desire was not relevant when compared with the placebo, researchers noted.
Among the health risks, the new drug may pose, the FDA mentioned low blood pressure, fainting and heightened risk of accidental injury. Flibanserin’s side effects were enhanced when women combined it with antifungal drugs they used to treat vaginal candidiasis or contraceptives.
Image Source: Time
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