FDA tells Sprout Pharma, like it or not the black box on Addyi stays, but we will dilute the warning

When the controversial first drug for low sexual desire in women was finally granted approval in 2015, critics accused the FDA of bowing to pressure from advocates by sanctioning the use of a drug that was found to be marginally effective in clinical trials, and dangerous when taken with alcohol. On Thursday, the agency rebuked the maker of the drug, Addyi, by refusing to entertain the company’s quest to discard the black box warning carried by the treatment, but agreed to dampen the strong warning on the basis of postmarketing data.