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FDA to Look at Chantix Labeling

October 24, 2008

U.S. drug regulators said they’re reviewing labeling of Chantix after reports of traffic accidents and seizures involving users of the anti-smoking drug.

The Institute for Safe Medication Practices said government safety data show there were 1,001 serious incidents involving patients taking varenicline, marketed by Pfizer as Chantix, in the first quarter of this year, the Wall Street Journal reported Thursday. The report said 15 cases were connected to traffic accidents and 52 cases involved blackouts.

The U.S. Food and Drug Administration said it is reviewing the reports “to see if current labeling related to accidents after varenicline is adequate.”

Pfizer has questioned the institute’s figures, saying the government safety data are “often unverifiable and lack sufficient medical information to draw any conclusions.”

The Wall Street Journal said media reports of psychiatric risks associated with Chantix may have resulted in increased reporting by patients and doctors.




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