Pill for Low Libido in Women Goes on Sale on Saturday
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FRIDAY, Oct. 16, 2015 (HealthDay News) -- The so-called "little pink pill" -- the controversial drug intended to boost flagging sex drive in women -- goes on sale on Saturday.
Flibanserin (Addyi) is the first U.S. Food and Drug Administration-approved drug designed to help women with low libido. But that approval, announced in August, came with significant restrictions because the drug can cause severely low blood pressure and loss of consciousness, the FDA warned.
Addyi's label will include a boxed warning saying the drug shouldn't be taken while drinking alcohol, and shouldn't be used with certain other drugs and by women with liver problems.
And the once-daily pill, to be taken at night, can only be prescribed or dispensed by doctors and pharmacists who have been thoroughly briefed on the drug and its benefits and risks, the FDA added.
"Today's approval provides women distressed by their low sexual desire with an approved treatment option," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement released Aug. 19. "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."
Woodcock said Addyi will only be available through certified health care professionals and certified pharmacies "because of a potentially serious interaction with alcohol."
Addyi is being marketed by Sprout Pharmaceuticals, based in Raleigh, N.C.
Dr. Holly Thacker, a women's health specialist at the Cleveland Clinic, said the FDA's approval of Addyi "provides an additional, helpful option for women across the country who experience sexual dysfunction. The medication has been studied in 11,000 women and it does improve sexual function in women who have certain sexual problems.
"It doesn't treat all sexual dysfunction, it won't help all women with sexual problems, but it will have a role in the therapy," Thacker added. "Just like with any medication -- adult women in conjunction with their physician can make an informed decision about whether this is an appropriate therapy for them."
Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York City, said: "Although the efficacy [effectiveness] of flibanserin is not clear, it seems to be safe. Couples will have the option of finding out for themselves whether or not it enhances their sexual relationship. It is clear that flibanserin will not address interpersonal or emotional problems. Nor will it address issues related to painful intercourse."
The pursuit of a drug for women with low libido has been like a Holy Grail for the pharmaceutical industry, given the enormous popularity and financial windfall from the erectile dysfunction drugs Viagra and Cialis for men since the late 1990s.
And Addyi's long road to FDA approval -- it had been rejected twice by the agency since 2010 -- was a contested affair.
Proponents said the drug would provide an important option for millions of American women who suffer from hypoactive sexual desire disorder, which causes a persistent or recurring lack of desire.
"This would bring another option to the table that doesn't currently exist," said Fred Wyand, spokesman for the American Sexual Health Association, a group that testified in favor of flibanserin during an FDA hearing in June.
But opponents cited a host of concerns about the drug. Among the concerns: symptoms of extreme fatigue and the potential for accidental injuries, as well as questions about the medication's effectiveness.
An FDA advisory panel voted 18 to 6 in June to recommend the drug's approval, but the endorsement was somewhat muted. The committee called the drug's benefits "moderate" or "marginal," and the panel members who voted yes said full FDA approval should come with conditions.
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