Advisers To FDA Recommend Agency Approve Drug To Boost Female Libido : Shots - Health News Proponents claim the Food and Drug Administration is applying a double standard to its review of a drug some call the female Viagra. Critics say flibanserin hasn't been proved safe or effective.
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Advisers To FDA Recommend Agency Approve Drug To Boost Female Libido

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Advisers To FDA Recommend Agency Approve Drug To Boost Female Libido

Advisers To FDA Recommend Agency Approve Drug To Boost Female Libido

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AUDIE CORNISH, HOST:

The Food and Drug Administration should approve the first pill designed to boost a woman's libido. That's the recommendation of an independent panel of experts the FDA assembled for a hearing today. NPR health correspondent Rob Stein has been following this story and joins us now with the details. Hey there, Rob.

ROB STEIN, BYLINE: Hey, Audie.

AUDIE CORNISH, HOST:

Let's start by talking about the drug itself. What's it called? How does it work?

STEIN: Yeah, this drug has been called flibanserin. Now, if the FDA actually goes along with this recommendation and approves the drug, the company says it's going to change the name and start selling it as Addyi. And here's how it works. It basically changes the levels of three hormones in the brain. It increases dopamine and norepinephrine and it decreases serotonin, and the idea here is it's supposed to increase the sex drive for premenopausal women suffering from something called hypoactive sexual desire disorder, which is basically a loss of libido.

CORNISH: And this isn't the first time the FDA's actually taken a look at this drug, right? I mean, tell us the history here.

STEIN: Yeah, actually this is the third time the FDA's considered this drug. Two previous times other FDA advisory committees rejected the drug, saying there just wasn't enough evidence that it actually worked and there was some concerns about side effects. Some women would - it caused their blood pressure to drop and they would faint. Some women, if they used the drug, would wake up the next morning feeling really groggy and drowsy, especially if they had drank alcohol while they were using the drug. And that was - caused concerns that it could increase their risk for accidents, like car crashes.

CORNISH: So did that actually fuel some controversy over this drug?

STEIN: Yeah. So the company that makes the drug and some outside advocacy groups, including, like, the National Organization for Women - NOW - basically accused the FDA of being sexist, saying they were demanding that this drug jump through many more hoops than drugs for male sexual problems like Viagra. And that that meant that the FDA just wasn't taking female sexual problems as seriously as male sexual problems and they pointed out that men who have sexual problems have many options. There are no drugs approved for women.

CORNISH: Now, Rob, what did the FDA actually say? How did they respond to these accusations, and then what about those experts?

STEIN: Yeah. So the FDA has flatly denied those accusations for a long time, and it did so again today during today's hearings. And they said, look, we've just been following the scientific evidence and there just wasn't enough evidence to approve the drug. And they got some support from some other groups, some women's health groups that basically agreed with them, saying, look, this drug doesn't seem like it works very well, if at all, and could have some serious side effects. And we have no idea what - if there are long-term side effects, women would have to take a psychoactive drug every day for the rest of their lives.

CORNISH: As for the hearing today, what happened?

STEIN: So it was a daylong hearing, and they heard a lot of evidence. The FDA scientist came in and they said, look, there is evidence that this drug can increase libido. It can increase the number of satisfying sexual experiences that women have and decrease the amount of stress they're experiencing, but they still were concerned about these side effects. And they said the effects - the benefits seem still to be modest. The company made its case and presented some new evidence saying, look, there's a lot - we've tested this drug on thousands of women. The effects may be modest, but for the women it helps, it helps a lot. It makes a big difference in their lives and that the side effects seem to be very mild and very rare. And there were some really - some very emotional testimony from women suffering from a loss of libido, describing how it had affected their lives, how it had affected their marriages, some risked getting divorced and they - really made them miserable. And then on the other side, there were advocates who were saying, look, this drug, you know, we really just don't know enough about it. The benefits seem so minor that it's not worth the risks. In the end, the committee voted pretty overwhelmingly 18 to six to approve the drug with the caveat that the steps be taken to make sure any risks were minimized.

CORNISH: What happens now?

STEIN: Well, the FDA doesn't have to follow the advice of its advisory committees, but it usually does.

CORNISH: That's NPR's health correspondent Rob Stein talking to us about a panel that's recommended that the FDA approve a drug to treat low libido in women. Rob, thank you.

STEIN: Oh, sure, nice to be here.

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