Government health experts are backing an experimental drug intended to boost the female sex drive, but stress that it must carry safety restrictions to manage side effects including fatigue, low blood pressure and fainting.
The Food and Drug Administration panel voted 18-6 in favor of approving Sprout Pharmaceutical’s daily pill flibanserin, on the condition that its manufacturer develops a plan to limit safety risks.
The positive recommendation is a major victory for a drug sometimes hailed as “female Viagra,” but which has been plagued by for years by concerns about its lackluster effectiveness and safety issues. The FDA has twice rejected the drug since 2010.
Witness after witness stepped up Thursday to beg the Food and Drug Administration to approve a “little pink pill” that promises to restore sexual desire to women who have lost it.
“My desire for sex has left the building like Elvis’s blue suede shoes,” Amanda Parrish, a mother of four from Nashville who’s been an outspoken supporter of the drug, told a meeting of FDA advisers who are considering approval.
But critics say it’s not clear the drug actually fixes the problem, and they say once it’s on the market, thousands of women will be taking it every day. The potential side-effects could be numeorus.
The pill, known by its generic name, flibanserin, is commonly called the female Viagra. But unlike Viagra, it works on the brain. Viagra affects blood flow to the genitals.
Parrish says flibanserin helped her when she tried it. “As if a light switch had been turned on, so was I,” she said.
There’s been a lot of controversy over flibanserin (pronounced fluh-BAN-ser-in). The FDA has asked for extra studies on the drug and better measures of the problems it’s supposed to fix.
And some experts say there’s no such thing as the medical condition that drugmakers want to market flibanserin for – hypoactive sexual desire disorder, or HSDD.
“Hypoactive sexual desire disorder was actually invented by pharmaceutical companies,” says Dr. Adriane Fugh-Berman of Georgetown University Medical Center.
“It was originally invented to sell the testosterone patch. And certainly there are women that have low libido, but that can be caused by many different things, including medications, such as the birth control pill and antidepressants and blood pressure medicines, for example.”
But experts testifying at a meeting outside Washington say it’s a real disorder that greatly distresses some women. They argue that up to 7 percent of women have the condition, which by definition isn’t caused by depression or other medical conditions.
“HSDD has been recognized as a medical disorder for almost four decades now,” Sheryl Kingsberg, a clinical psychologist and professor of reproductive biology at Case Western Reserve University School of Medicine, told the meeting.
Kingsberg, a paid consultant to Sprout Pharmaceuticals, the company seeking FDA approval for the drug, says she’s seen many patients with HSDD. “No longer does she initiate sex or feel responsive to sexual advances,” Kingsberg said. “That drive has been gone for a long time – months and, more commonly, years – before she finds her way to my office.”
