Female Viagra Approved! But It Comes With a Warning

A new drug that treats low sexual desire among women was approved on August 18, 2015 by U.S. health regulators. However, they warned that there are a number of side effects to watch out for when taking the medication.

Reuters reported that the new drug, flibanserin, commercially known as Addiyi, will only be available through pharmacies and certified health care professionals. Addiyi is the first drug approved for the condition by the U.S. Food and Drug Administration (FDA). The drug flibanserin, made by Sprout Pharmaceuticals, was previously rejected twice by the FDA. The drug was originally developed by Germany-based firm BoehringerIngelheim, but was rejected by the FDA in 2010 due to the risks outweighing the benefits. Sprout Pharmaceuticals subsequently acquired the drug and performed more studies. When another application for it was filed in 2013, the FDA again denied it.

After the two rejections by the FDA, many women protested, saying that the agency was biased towards men in allowing Viagra. They added that it should be up to them to determine whether the benefits outweigh the risks.

Addiyi does not work in the same manner as the highly popular Viagra pill for men that helped in erectile dysfunction. Women need to take Flibanserin daily. Viagra for men generally involved increasing blood flow to the genitals, while flibanserin acted on the brain. The female Viagra is the same as the class of drugs called selective serotonin reuptake inhibitors (SSRI). It works more like an antidepressant. The drug is ideal for premenopausal women who lack sexual desire, causing distress, based on the same Reuters report.

In a clinical study involving 11,000 participants, women who took Flibanserin showed an increase of about 1.0 sexually satisfying event (SSE) every month, compared to those who consumed a placebo. Many of the women reported having improved sexual mood regardless of their busy schedules.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option. The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) in a report by The Guardian.

The FDA also warned that there can be potential adverse reactions to the pink pill, such as low blood pressure and loss of consciousness. The drug can lead to adverse effects when taken with alcohol. Patients and prescribers are advised to completely understand the risks involved with the use of Addiyi before consumption or prescription.