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FDA Approves First Drug To Improve Libido For Women

DAVID GREENE, HOST:

Women will soon have something that men have had for years, a drug they can take to help improve their sex lives. The Food and Drug Administration yesterday approved the first drug designed to boost a woman's libido. As NPR's Rob Stein reports, this decision is getting some mixed reaction.

ROB STEIN, BYLINE: The drug is called Addyi. It's been approved to treat women suffering from a condition known as hypoactive sexual desire disorder. Cindy Whitehead heads Sprout Pharmaceuticals, the company that makes the drug.

CINDY WHITEHEAD: This condition causes really a distressing lack of interest in sex for women. And the impacts of that condition goes well beyond the bedroom.

STEIN: Whitehead says the condition can make women miserable. They want to want to have sex, but just don't. Their marriages often fall apart. Nevertheless, the FDA twice rejected Addyi, saying there just wasn't enough evidence it worked and big questions about its safety. That prompted Whitehead and some others to accuse the FDA of being sexist, especially since men have had drugs like Viagra for years.

WHITEHEAD: There's a societal narrative that really appreciates, I think, the biology of sex for men as witnessed by countless medical treatment options for them to address some of the disorders that can negatively impact sexual function. By contrast, I think we've really reduced all things related to sex and women to psychology.

STEIN: So the company launched a campaign to convince the FDA to reverse the decision. Whitehead was thrilled by yesterday's victory.

WHITEHEAD: Finally to have a medical treatment option is a very important advance for women.

STEIN: Some women's health experts and advocates agree. And Terry O'Neill of the National Organization for Women hopes Addyi will just be the first of many drugs to help women with sexual problems.

TERRY O'NEILL: Women need to have an array of choices that meets their specific medical needs. So with this success, I think there will be more development of more medications. And that is all to the good.

STEIN: But not everyone is happy with the FDA's decision. Other experts on female sexuality and women's health oppose the drug. They question how well Addyi works and whether it's safe. Among other problems, Addyi can cause a sudden drop in blood pressure that makes some women faint. Cindy Pierson is with the National Women's Health Network.

CINDY PIERSON: This drug either doesn't work at all or barely works. And the safety concerns are real troubling and not well enough understood so that women will be able to make an informed decision about how much risk they are willing to accept.

STEIN: Critics like Pierson charge the FDA was pressured to approve the drug by an intense lobbying effort sponsored by the company.

PIERSON: This decision is a victory for marketing and for corporate skullduggery. It's not a victory for women's rights.

STEIN: The FDA is requiring the drug to carry some warnings to make sure women use it safely. For example, women will be advised not to use something else to get them in the mood while taking Addyi - alcohol. It will be available by prescription in October. Rob Stein, NPR News. Transcript provided by NPR, Copyright NPR.

Rob Stein is a correspondent and senior editor on NPR's science desk.
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