The "Little Pink Pill" or "Female Viagra"

08/25/2015

The "Little Pink Pill" or "Female Viagra"
Healthy Living – August 26, 2015
Garrick Slate, MD

Flibanserin (Brand Name Addyi) has just been approved by the FDA to treat Hypoactive Sexual dr-slate-(1).jpgDesire Disorder (low sexual desire), or in other words, boost a woman’s libido.

Sprout Pharmaceuticals, the company that manufactures Flibanserin, was just purchased by Valeant Pharmaceuticals for $1 billion.

This is the first-ever FDA approved drug to boost libido (sexual desire). The drug will hit pharmacy shelves on October 17, 2015. The drug must be taken daily, not just around the time of desired effect.

However, there is just one concern: the “little pink pill” does not really work that well. The FDA has rejected Flibanserin twice before, and only approved the drug this time after powerful marketing and an advocacy campaign from women’s groups.

There are five reasons to be skeptical of Flibanserin (Addyi) as a “Viagra equivalent:”

Flibanserin does not help most women.
  • Only 8-13% of women will see improvement.
  • Women taking the daily drug had on average only 0.5 more “sexually satisfying events” per month compared to women on placebo.
  • The drug does not lead to increased desire - a false hope held by many individuals.
  • It only works in women in relationships who have described an overall decrease in sexual desire.
  • Women’s sexuality is very complex - this is not treating a functional problem, rather it has a mood-stabilizing/desire-stabilizing effect.
Flibanserin has scary side effects.
  • Twenty percent of all women taking the drug reported adverse events.
  • Most common were drowsiness, dizziness, and fainting, which increased the risk of trauma and head injuries such as concussions.
  • Extremely low blood pressure was another, less common, side effect that could have major consequences.
  • When taken with either alcohol or hormonal birth control the side effects could be markedly worse.
Doctors worry about drug interactions.
  • Given the potential for extreme side effects, the drug will only be available through specially certified health care professionals and pharmacies that have received additional training about the drug.
  • Doctors will have to assess a patients’ ability to stay away from alcohol for the duration of their treatment and to take exactly as prescribed (at bedtime).
  • Women may still drink while taking this medication.
  • Women may still use hormonal contraceptives while on this medication.
  • Women may use the medication “off label” or in ways not described for use such as in menopause or in women with undiagnosed medical conditions like heart disease.
  • The alcohol impact study performed by the company only included 25 participants - only two were women.
  • Studies were only performed using healthy women not on sleep aids, anti-anxiety medications, or any other medications that women commonly take that could potentially have serious interaction side effects.
The campaign behind Flibanserin approval is misleading.
  • Flibanserin had been rejected twice - most recently in 2013.
  • No evidence changed and no new evidence was submitted for this approval.
  • Major victory for marketing - “even the Score” campaign designed to “even the playing field”
  • There are 26 medications to treat male sexual dysfunction, but no medications to treat low libido in males.

Approval has been described as a “textbook case of disease-mongering” by the pharmaceutical industry.
  • Many critics have accused the pharmaceutical industry of inventing the disease condition called Hypoactive Sexual Desire Disorder so that they could invent a drug to treat the condition.
  • Flibanserin was shown in trials to have very limited efficacy with potential for big, potentially life-threatening side effects.


References:

Julia Belluz, VOX Explainers (www.vox.com)
Debra Goldschmidt, CNN, “Female Viagra” gets FDA approval