Why FDA decision on Flibanserin or Female Viagra is matter of debate?

Soon we will hear the FDA announcing its decision on flibanserin or female Viagra. Before that, the tiny pink pill has become a topic of serious debate.

Women struggling with low libido will soon get a medication to fight the situation. Last week, an FDA panel approved a drug called flibanserin; it’s a drug formulated for boosting female libido and amplifying the levels of sexual satisfaction in women.

Flibanserin is currently on the brink of reaching the stores; however, the drug has a long history, which includes a decade of formulation, elaborate clinical trials and a couple of previous attempts for acquiring FDA approval.

As mentioned above FDA’s advisory panel has already approved the pill; the agency will be taking its final decision by August 18, 2015.

Although many are saying that the drug has been long overdue and will be addressing a massive unmet need, the tiny pink pill has also gave birth to controversies. The female sexual disorder the pill is meant to treat has also been a topic of serious debate.

Two years back, the condition called hypoactive sexual desire disorder (HSDD) was removed from the Diagnostic and Statistical Manual of Mental Disorders. A new disorder called FSIAD or female sexual interest/arousal disorder was adopted. The change was made primarily because of confusions regarding the distinction between female arousal problems and issues related to their sexual desire.

There has also been confusion regarding whether women can develop sexual dysfunction. During a study conducted in 1992, researchers detected sexual dysfunction in 43% women; however, a few questions asked during that study were later tagged as disputed. Other studies conducted on the same subject suggested that sexual dysfunction exists in one in every ten women, which makes the rate of incidence 10%.

Although many think that the soon-to-be launched pink pills are equivalents of the blue pills or Viagra formulated for men, it’s not true. Due to this belief, the pink pill flibanserin has been nicknamed as “female Viagra”.

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The fact is that Viagra has been designed for treating erectile dysfunction resulting from blood flow issues in men. The medication treats a mechanical issue; it is not meant to treat problems like lack of sexual desire.

Flibanserin, on the other hand, was originally meant to work like an antidepressant. It works on neurotransmitters of women and must be consumed every day. As a result, flibanserin cannot be tagged as an equivalent of the blue pills; it is a new class of drugs. Once released officially, it will be the first ever sexual desire inducing pill to hit the market.

In spite of being so different from Viagra, flibanserin will find it difficult to get rid of its nickname “female Viagra”, which might help Sprout Pharmaceuticals, the drug’s manufacturer to market the medication more easily.

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The nickname has also turned out to be handy for some supporters of the new drug; these are people who are seeing the launch of Flibanserin from a feminist point of view. These supporters of flibanserin are hoping that the drug will succeed in having a similar impact on lives of women as birth control pills did more than five decades back.

The FDA has also been accused of being sexist by Sally Greenberg, the executive director of National Consumers League. For those who don’t know: National Consumers League is a nonprofit advocacy group that lobbied against the agency for approving flibanserin.

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According to Greenberg, in 1998, the FDA took just six months to approve Viagra in spite of knowing about possible serious side effects of the drug, for instance, blindness, stroke, and death; she added that the same agency rejected flibanserin twice showcasing concerns about the drug’s efficacy and adverse effects such as faintness, low blood pressure, and nausea. Greenberg said that such behavior of FDA can only have one reason, and that is gender bias.

However, many experts associated with the world of sexual health don’t support Greenberg’s view. One such individual is Dr. Peter Weiss, the executive director of the Beverly Hills, CA-based Rodeo Drive Women’s Health Center. According to him, the FDA shouldn’t approve a drug with known adverse effects just to showcase that it believes in equality for women.