Key Highlights
- 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.
- Sales of Addyi, which acts on brain chemicals that affect mood and appetite, have been limited.
