A take: The latest FDA approval was a huge mistake

On Friday, the FDA approved a treatment meant to increase women’s sexual desire, a drug with marginal effects and a sizable risk of nausea. And that, argues STAT’s Adam Feuerstein, is why approving it was the wrong decision.

First, there’s the efficacy: In clinical trials, only 8% more of the women who took the drug saw an even modest increase in sexual desire. And when it came to distress, the difference between drug and placebo was 4%. Then there’s safety: 40% of women treated reported nausea, and the treatment led to a darkening of the gums and skin on the face and breasts in about 1% of women.

That all adds up to drug whose benefits don’t justify its risks, according to Feuerstein, and yet the FDA approved it anyway. That’s bad for patients, he argues, and it could end up being bad for AMAG Pharmaceuticals, the company that will now try to market a problematic product.

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