Why I Hope The FDA Approves "Female Viagra"

The US Food and Drug Administration has now approved the first drug in the United States to treat a low libido in women. Nicknamed the “female Viagra,” flibanserin is said to treat hypoactive sexual desire disorder, or a persistent lack of sexual desire in premenopausal women. (Despite the nickname, the drug functions differently than Viagra it targets chemicals in the brain rather than increasing blood flow to the genitals.) The so-called disorder is said to affect nearly 1 in 10 women.

But safety restrictions on the daily pill, called Addyi, mean it will probably never achieve the blockbuster sales of men’s impotence drugs like Viagra, which have generated billions of dollars. The new drug’s label will carry a bold warning that combining it with alcohol can cause dangerously low blood pressure and fainting. Those problems can also occur if the drug is taken alongside certain common medications, including drugs used to treat yeast infections.

The Food and Drug Administration approval on Tuesday marks an unusual turnaround for the agency. The FDA previously rejected the drug twice due to lackluster benefits and worrisome side effects. When it comes to problems in the bedroom, men have long had several pharmaceutical options but women were typically out of luck. That begins to change today.

What is ‘female Viagra’? Is it safe? And what happens next?

Also unlike Viagra, which is taken on an as-needed basis, flibanserin is effective only if taken every day. Because the drug can cause sleepiness, Sprout recommends taking it before bed. Adriane Fugh-Berman, a pharmacology professor at Georgetown University and director of Pharmed Out, which focuses on pharmaceutical marketing practices, called Tuesday “a sad day for drug regulation.”

“The FDA turned down this drug twice because the risks outweighed the benefits,” she said. “What has been learned since the last disapproval is that it has more risks than we thought and it doesn’t have any more benefits. The only thing that’s different is a clever, aggressive public relations campaign that Sprout Pharmaceuticals waged successfully.”She added: “This opens the way for drug companies to pressure the FDA through public relations campaigns to approve more bad drugs: It’s bad news for rational drug approval.”

The FDA rejected the drug in 2010 and in 2013, saying the risks of side effects such as nausea, dizziness, low blood pressure, fainting and sleepiness outweighed the “modest” benefit. In June, however, an FDA advisory panel voted 18 to 6 to recommend approval. That vote came after Sprout conducted additional safety testing and measured the drug’s impact on sexual desire over 28 days, not daily as in earlier studies. The FDA concluded there was a “statistically significant” improvement over a placebo..... Read More.....