Quantcast
The FDA Has Finally Approved Female Viagra

But they're also putting their strongest warning label on the package.

Looking for in-depth coverage of medical science?

A Treatment for Alzheimer's Might Lie in the Brains of Hibernating Bears

The Cyclists Crowdfunding a Medical Cannabis Trial

New Research Offers a Bleak Perspective on Algorithmic Medicine

Flibanserin, the so-called "female viagra," was finally approved by the federal Food and Drug Administration Tuesday, ending a years-long struggle to get the controversial drug on the market. Marketed under the pronunciation-resistant name "Addyi," it's the first medication ever approved for the treatment of generalized hypoactive sexual desire disorder (HSDD). In other words, it's the first drug ever approved that specifically helps women have more sex.

How it does that is still unclear. Much like Prozac, Addyi futzes with the patient's brain chemistry. Unlike Viagra, which works by giving already-horny men boners when they previously couldn't get boners, Addyi was shown to be effective in a more obscure way: in trials, women taking the drug had sex just slightly more often than women who were taking a placebo, for whatever reason. Whether the drug accomplished this by making sexual partners look hotter, or by making sex sound more fun, or by just generally improving female sex drive, hasn't yet been determined.

And unlike Viagra, Addyi has to be taken every day, as opposed to just on date nights when the kids aren't home. It also has to be taken for weeks before a patient will feel any effect. The drug was rejected twice by the FDA in 2010 and 2103, because the effect was too slight, and because it had shown too many side effects in trials, including dizziness and nausea, along with drowsiness and fainting—potentially interrupting the user's more frequent bouts of hot sex.

While the drug can now go to market, the FDA will employ its gravest packaging alert, the notorious "Black Box Warning," used only when the FDA really wants you to reconsider taking a drug. Essentially, the warning tells women that if they drink alcohol while they're on Addyi, they might faint and hit their heads.

Follow Mike Pearl on Twitter.