6 reasons to be skeptical of the new “Female Viagra”
There is much controversy over the August 18, 2015 FDA approval of a new drug, Filbanserin which purportedly will treat condition of “Female Hypoactive Sexual Desire Disorder, which was renamed “Female Sexual Interest/Arousal Disorder in 2013.
An interesting article by Julia Bellez in Vox.com summarizes some of the concerning issues related to this drug’s approval. As a result of this recent FDA approval, the drug, Addyi, will hit the market this October.
Six reasons to be skeptical about flibanserin are:
- Flibanserin has to be taken daily and takes, on average, 4 weeks of therapy before an effect is noted. And “peak” results don’t occur for 8 weeks.
- The effect was pretty minimal. Women on the drug experienced 4.4 “satisfying sexual experiences per month vs those on placebo, who experienced 3.7 satisfying experiences per month. That is only about ½ of a sexual experience aided by the drug.
- Women experienced fairly dangerous side effects if flibanserin was taken with alcohol – 17% incidence of low blood pressure and fainting, after only 2 glasses of wine. However, as the National Women’s Health Network stated in their op-ed, of the 25 people in the alcohol side effect study, only 2 women were included!
- In fact, this side effect issue was such a liability, that the company requires that clinicians and pharmacists who prescribe flibanserin take a course about risks before being certified to prescribe it.
- It was only approved for premenopausal women, when experience shows the problem to be at least as prevalent, if not more prevalent, in older women.
- The mechanism of action of the drug lies in the brain and central nervous system, in contrast to the drugs for erectile dysfunction in men. In fact, flibanserin was originally studied in the area of antidepression therapy.
In fact, the National Women’s Health Network and Georgetown University’s Pharmed Out organization have taken a very strong stance against the approval of this drug.
SGWHC applauds the thoughtful work of these advocacy organizations which have spoken out against the approval of a drug which appears to have a very minimal positive effect for Hypoactive Sexual Desire Disorder in women, and a fairly serious side effect profile.