Female Libido Pill Caused Dissent in FDA Ranks, Memo Shows
- At least three reviewers recommended against Addyi approval
- Managers determined benefit of the drug outweighs the risk
Meet Addyi, the FDA-Approved Women's Sex-Drive Pill
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Addyi, the pink pill for women with low libido, was approved by the Food and Drug Administration last month even though at least three FDA reviewers recommended rejecting it.
They warned about possible side effects and expressed concern that “the marginal clinical benefits do not outweigh the serious risks,” according to a memo posted online that summarized the analysis within the U.S. regulatory agency. More than a dozen offices reviewed the drug, though the memo doesn’t make clear how many people raised concerns. One reviewer particularly wanted more study of the interaction between Addyi and alcohol because the tests were conducted almost exclusively with men.