Link Between Chantix, Psych Symptoms Likely: FDA

Law360, New York (February 1, 2008, 12:00 AM EST) -- The U.S. Food and Drug Administration issued a public health advisory Friday for a smoking cessation drug made by Pfizer Inc. after reviewing adverse event reports of agitation, depression and suicide.

The FDA has been reviewing the reports for Chantix, a brand name for varenicline, and has come to the conclusion that it is “increasingly likely” that there's an association between the drug and serious neuropsychiatric symptoms, the agency said.

The agency said it had asked Pfizer to elevate the prominence of safety information to the...
To view the full article, register now.