FDA Exacts Tougher Labels For Anti-Psychotic Drugs

Law360, New York (June 16, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has opted for a stiffer warning for an older class of anti-psychotic drugs that includes Johnson & Johnson's Risperdal, concerned that even this “conventional” line of medications can increase the risk of death when used to treat dementia patients.

On Monday, the FDA demanded that manufacturers make safety-related changes to the labeling of this group of medications, pointing to a higher risk of death associated with this particular off-label use.

"It is important that health care professionals and consumers have...
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