Female Viagra Gets FDA Approval; Critics Ask Why

ViagraEarlier this month, a panel of advisors for the US Food and Drug Administration (FDA) voted 18-6 in favor of approval of a flibanserin, a pink pill touted as the “female Viagra.” The final decision on whether or not this controversial drug will go to market comes in August. This panel vote is the third since 2010 for flibanserin and the only one that met with enough votes to approve it for further consideration. Critics of the drug are asking why now.

Flibanserin History, Benefits, Side Effects

Flibanserin was first developed as an antidepressant; it works on serotonin, dopamine, and other mood-influencing brain chemicals. Some women who took it in clinical trials reported increased sexual satisfaction while taking the daily antidepressant, a finding that led its developer to launch a campaign to market the drug as a treatment for hypoactive sexual desire disorder (HSDD), or lack of interest in sex profound enough to cause emotional or relationship distress.

When tested as an aphrodisiac, women reported one or fewer additional satisfying sexual events each month than women in a control group taking a sugar-based placebo instead of the drug.

The drug comes with side effects so severe 14% of the women in clinical trials drop out to avoid them. Common side effects include fatigue, low blood pressure, and fainting, all of which increase the risk of dangerous falls; one woman developed a concussion when she fainted during a clinical trial.

The drug was denied FDA approval twice since 2010, when it was unanimously rejected due to dismal results and dangerous side effects. Its original developer sold it to Sprout Pharmaceuticals, a company that was founded solely to bring flibanserin to market.

Many women’s professional and advocacy organizations, including the Association of Reproductive Health Professionals, the National Association of Clinical Nurse Specialists, and the Society for Women’s Health Research, applaud the FDA preliminary approval vote.

Opposition on Many Fronts

Sprout wants to market the drug to premenopausal women with HSDD, a condition many physicians do not recognize as legitimate, especially since it was removed from the American Psychiatric Association’s Diagnostic and Statistical Manual of Disorders in 2013; the manual is the only medically accepted reference guide for all psychiatric diagnoses, including those of a sexual nature.

The company claims HSDD affects 10% of all premenopausal women but doubts about the diagnosis itself make the claim difficult to accept.

The benefits identified in clinical trials are minimal at best and almost nonexistent when compared to women not taking the drug.

The known side effects can be serious enough that its danger outweighs the benefits of flibanserin. The risk of side effects increases when flibanserin is taken with alcohol, birth control pills, fluconazole (often prescribed to treat vaginal yeast infections), and other common medications.

The drug has been inadequately tested to prove its safety with alcohol. Sprout has conducted only one small study of flibanserin-alcohol interaction; the study involved 25 participants, most of whom were men.

With such an inadequate track record for testing, critics ask why now, before more thorough testing can confirm safe, valid benefits of the drug.

Flibanserin targets the brain chemicals that influence libido, making it quite different from Viagra, which targets performance caused by inadequate blood flow to the genitalia, leading to erectile dysfunction.

That the drug won preliminary approval after two absolute disapproval votes leads critics to question the integrity of the FDA approval process. Sprout is investing all its money into getting the drug to market, leading some critics to fear FDA approval may come with a price tag instead of patient safety in mind. The concern is how easy it might become for other unproven drugs to get approval for the right price in the future.


Sources:

  1. Pollack, Andrew. "'Viagra for Women' Is Backed by an F.D.A. Panel." The New York Times. The New York Times Company, 4 June 2015. Web. 17 June 2015.
  2. Perrone, Matthew. "FDA Panel Backs Female Libido Pill, Under Safety Conditions." AP / Associated Press. The Associated Press, 4 June 2015. Web. 17 June 2015.
  3. "Even The Score Applauds FDA Advisory Committee as It Makes #Herstory by Recommending Approval of First-Ever Medical Treatment for Women's Most Common Sexual Dysfunction." Even the Score / The Buzz. Even The Score, June 2015. Web. 17 June 2015.