By Igor Volsky and Victoria Fleischer
The Food and Drug Administration (FDA) approved flibanserin (Addyi) popularly known as “the female Viagra,” on Tuesday after twice rejecting the therapy.
Flibanserin, manufactured by Sprout Pharmaceuticals, is intended for pre-menopausal women who suffer from Hypoactive Sexual Desire Disorder (HSDD) — a condition characterized by impairments in sexual function as well as sexual desire that isn’t caused by mental illness, medications, or another medical condition. Though some supporters are heralding the drug’s approval as a milestone for women’s sexual health, critics say it could be ineffective or even dangerous in the general population.
The favorable decision comes after Sprout Pharmaceuticals partially financed a public relations campaign accusing the federal government of a gender bias in medical research and petitioned women’s groups, female members of Congress, and the general public to lobby the FDA to “even the score” with male sexual drugs and approve this medication for women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
But Cindy Pearson, the executive director of the National Women’s Health Network, lambasted the campaign for spreading “lies” about the medication and downplaying its adverse effects. The drug can cause dizziness, lightheadedness, fainting, a drop in blood pressure, and sedation in approximately one in five women. It cannot be mixed with alcohol, some forms of hormonal birth control, and a long list of other medications.
Clinical trials showed that 8 to 13 percent of women who took the drug saw some improvement in sexual desire, demonstrating, on average, “an increase of 0.5 satisfying sexual events per month.”
“I’m afraid that a drug that hardly works at all and is somewhat dangerous is going to be out on the market and hailed not only as a new type of drug for women, but as a breakthrough in women’s equality,” Pearson said in an interview conducted before the drug was approved. “It’s going to be used by people who it wasn’t tested in and it’s going to be used by people who aren’t as healthy as the women who volunteered for the test and this evidence that we already have of injuries caused by the drug is going to escalate into very bad injuries if not even deaths that come about as a result of accidents that happen.”
The owners of Sprout Pharmaceuticals have previously relied on misleading marketing tactics. According to the Associated Press, the husband and wife team who own the North Carolina-based pharmaceuticals company ran afoul of FDA rules in 2010 while marking an implantable testosterone pellet for men. In a strongly worded letter, the FDA highlighted “a host of misleading, unsupported and inaccurate statements in its brochures, websites and a video” and even held a teleconference to air its “serious concerns” about the pellets.
In pushing for flibanserin’s approval, Sprout stood behind a campaign that claimed the FDA had approved 26 drugs for male sexual dysfunction and zero for women, compared the drug to Viagra, and even relied on the results from an alcohol interaction study that included 23 men and just two women.
“Viagra and other drugs that are totally different from this drug in almost every conceivable way except for that they have something to do with something sexual,” Dr. Caleb Alexander, the co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins University, said. He also characterized the company’s claim that it could not find more women to participate in the alcohol study as one that “lacks credibility.”
Alexander was part of an FDA advisory committee that recommended approval of flibanserin in June, though almost all of the 18 panelists who voted for the drug insisted that approval come with restrictions and expressed skepticism about its effectiveness. Alexander joined five other panelists in voting against approval.
“There are minimal effects of clinical significance and women suffering from HSDD deserve better than this,” Dr. Kathryn Curtis, who voted for flibanserin, said at the hearing. Dr. Til Sturmer, another “yes” vote, warned that “the overall magnitude of the benefit is not striking and there is some tendency for the magnitude to be less pronounced in those most severely affected by the condition.”
The FDA approved flibanserin with restrictions on how it can be dispensed — it “will only be available through certified health care professionals and certified pharmacies” — though the experts ThinkProgress consulted agreed that they are often ineffective and warn that the drug could be prescribed very differently from how it was approved. “Approval with conditions almost never works in the way that we would like it to,” Pearson explained. “It can if there are such strict controls on how the drug is prescribed that it really is limited just to the most narrow group of people who are most likely to benefit and least likely to be harmed, but that requires a level of control that’s pretty onerous and most drug manufacturers won’t go along with that.”
“In the absence of this crucial information, the FDA is counting on women to abstain from alcohol while using flibanserin, in spite of the fact that there is no known intervention… that can ensure people abstain from alcohol in the long term when consumption significantly increases serious risks from other medications,” she added in a statement after the drug was approved.