FDA Strengthens Gardasil Label's Fainting Warning

Law360, New York (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...
To view the full article, register now.