Our Bodies, Our Blog

FDA Panel Approves ‘Female Viagra” Despite Lingering Safety Concerns

By Guest Contributor |
FDA Briefing Document, June 4, 2015

by Martha Kempner, RH Reality Check

A Food and Drug Administration (FDA) advisory panel last week recommended that the government approve flibanserin, a drug that has often been called the female Viagra.

The panel voted 18-6 in favor of Sprout Pharmaceutical’s drug application on the condition that the company develops plans to manage the risks of the medication, which include fatigue, low blood pressure, and fainting. The FDA had previously rejected two applications for approval, citing concerns over side effects and lack of information about drug interaction. [View the FDA briefing documents.]

If the FDA takes the panel’s recommendation, flibanserin will be the first drug on the market designed to increase sexual desire in otherwise healthy women.

There has been a heated debate over whether women need a drug for low sexual desire, as RH Reality Check has reported. Some point out that it has been decades since the FDA approved Viagra for men and that women should have a medical option to help them fulfill sexual desires.

Others argue that marketing such a drug to women will merely put more pressure on them to have the “right” amount of sex and allow drug companies to profit off of their insecurities.

There is also some concern over flibanserin because, unlike Viagra, which acts immediately to increase blood flow to the penis and is only taken when needed, this drug works on brain chemistry and must be taken every day. [See “Why Doesn’t a Viagra Equivalent Exist for Women”]

Originally developed as an anti-depressant, it affects neurotransmitters in the brain — increasing levels of dopamine and norepinephrine and decreasing levels of serotonin. This seemed to increase some women’s desire for sex in trials.

Critics say the effects are not strong enough to warrant a daily drug. In the trials, women taking flibanserin reported between 0.5 and one more sexually satisfying event per month, compared with women taking a placebo. They also scored higher on questionnaires measuring desire and scored lower on measures of stress.

The drug has a number of side effects, including nausea and a sleepiness that was so severe in some women, it prevented them from driving.

In their presentation to the advisory panel on Thursday, FDA medical officers focused on these side effects and questioned whether they outweighed the benefit of the drug. They also expressed concerns about flibanserin’s interaction with other drugs and alcohol.

FDA officials pointed to a two-year study that suggested an increase of breast cancer in mice given four times the clinical dose of the medicine. They suggested that the 18-month clinical trials of flibanserin were not sufficient to rule out cancer risk.

The advisory panel also heard from some people who felt strongly that the drug was unnecessary.

Liz Canner, a filmmaker who produced the documentary, “Orgasm, Inc.,” which examines the search for a female sexual enhancement drug, said the company had “deceived women into taking a drug that doesn’t work better than drinking a glass of wine or two, and could end up killing us.”

“To approve this drug would set the worst kind of precedent: that companies that spend enough money can force the FDA to approve useless and dangerous drugs,” said Dr. Adriane Fugh-Berman of Georgetown University.

More than 30 of those who testified — including health-care providers and a number of women who had participated in the trials — urged the panel to support the drug. One provider stood at the microphone in awkward silence to illustrate how little she has to offer her patients with low sexual desire.

“I want to want my husband, it is that simple,” Amanda Parrish, a mother of four from Nashville, told the panel. “For us, flibanserin is a relationship-saving and life-changing drug.”

After the vote, advisory committee members enumerated conditions they would recommend accompany any FDA approval. These included warning labels, an education program, and prescriber training and certification.

Flibanserin would be labeled for pre-menopausal women with hypoactive sexual desire disorder (which is described as a lack of sexual appetite that causes emotional distress). Before prescribing it, health-care providers would have to rule out a number of alternate causes of low desire, including depression, relationship problems, and mood disorders.

The advisory panel’s recommendation is not binding, but the FDA often follows their advice. A decision is expected by the end of the summer.

This article first appeared on RH Reality Check and is reprinted with permission.