Doubts raised

“Female Viagra” caused dissent at FDA, memo shows

REUTERS/Eric Gaillard

Addyi, the pink pill for women designed to increase women’s libido, was approved by the Food and Drug Administration last month, in spite of the fact at least three FDA reviewers recommended rejecting it. Concerns were aired about possible side effects and the likelihood “the marginal clinical benefits do not outweigh the serious risks,” according to a memo posted online. One reviewer expressed the opinion that more needed to be known about the interaction between Addyi and alcohol, because the testing was conducted almost exclusively on men. The drug, manufactured by Sprout Pharmaceuticals Inc., is understood to be an effective treatment for only about 10 percent more patients than a placebo, the memo notes. It also can cause low blood pressure and fainting, especially if patients drink alcohol while taking it. In an effort to manage associated risks, doctors who prescribe Addyi must take an online training course, and patients must sign a form acknowledging the risks.

Read the full story at Bloomberg.

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