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FDA Strengthens Gardasil Label's Fainting Warning

Law360 (June 11, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has approved adding a more prominent warning to the packaging of Gardasil, a vaccine manufactured by Merck & Co. Inc. that protects against a virus that causes cervical cancer, to highlight a risk of fainting.

The changes would caution users that Gardasil vaccinations have caused “syncope, sometimes associated with tonic-clonic movements and other seizure-like activity,” the agency announced on Tuesday.

Syncope, or a temporary loss of consciousness, and tonic-clonic movements, or jerking, would be added to the list of warnings...
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