U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now be taken by women older than 65.
The announcement Monday from the Food and Drug Administration broadens the drug’s use to older women who have gone through menopause. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive.
Addyi, marketed by Sprout Pharmaceuticals, was initially expected to become a blockbuster drug, filling an important niche in women’s health. But the drug came with unpleasant side effects including dizziness and nausea, and it carries a safety warning about the dangers of combining it with alcohol. The boxed warning, FDA’s most serious type, cautions that drinking while taking the pill can cause dangerously low blood pressure and fainting.
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