FDA Approves Controversial "Viagra" for Women

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The federal Food and Drug Administration has given its approval to the controversial drug flibanserin (Addyi), also known as “pink Viagra.” It is the first-ever drug aimed at increasing women’s libido.

“[The] approval provides women distressed by their low sexual desire with an approved treatment option,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

Sprout Pharmaceuticals, which will manufacture Flibanserin, said that up to one in ten women have hypoactive sexual desire disorder (HSDD), the condition the non-hormonal medication is designed to treat.

According to a news release from the FDA, HSDD is characterized by low sexual desire that causes “marked distress or interpersonal difficulty.” It’s not due to any simultaneous medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. The non-hormonal drug is approved to treat premenopausal women.

Flibanserin has a troubled history. In 2010, an FDA panel unanimously rejected the drug. Experts have been concerned about two side effects: low blood pressure (hypotension) and loss of consciousness (syncope).  The risks of these side effects are increased with alcohol consumption, so patients taking flibanserin should not drink alcohol.

In June, ThirdAge wrote about the dangers of the drug. Click here to read the article.

According to the FDA, flibanserin is being approved with a boxed warning to highlight the severe risks to patients who do drink alcohol. The agency also said that its approval of the drug is accompanied by the risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU).

The REMS requires that flibanserin prescribers be certified with the REMS program by enrolling and completing training. Additionally, the agency said, certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with flibanserin.

Pharmacies must also be certified with the REMS program and can fulfill prescriptions only from certified providers. Pharmacists must also counsel patients about the risks of alcohol.

In addition, the FDA is requiring Sprout Pharmaceuticals to conduct three “well-designed” studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

Before flibanserin was approved, it was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years.

The FDA said it encouraged both consumers and health care professionals to report adverse reactions from the use of flibanserin o the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.