FDA panel backs female libido pill with safety conditions
WASHINGTON - Government health experts are backing an experimental drug intended to boost the female sex drive, but stress that it must carry safety restrictions to manage side effects including fatigue, low blood pressure and fainting.
The Food and Drug Administration panel voted 18-6 in favor of approving Sprout Pharmaceutical's daily pill flibanserin, on the condition that its manufacturer develops a plan to limit safety risks.
The positive recommendation is a major victory for a drug sometimes hailed as "female Viagra," but which has been plagued by for years by concerns about its lackluster effectiveness and safety issues. The FDA has twice rejected the drug since 2010.