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Chantix Safety Warning
The U.S. Food and Drug Administration warns that Pfizer Inc’s quit-smoking drug, Chantix, is associated with seizures and that some patients who drink while taking the drug may become aggressive or black out.
The agency said it approved an update to the drug’s label in 2014 but issued the public notice to ensure patients are aware of the changes “and can consider this new information when making prescribing decisions.”
Typically such warnings are made at the time of a label change.
Chantix, known chemically as varenicline, was approved in 2006. The FDA subsequently updated the label to include a warning, highlighted by a black box, of neuropsychiatric side effects, including suicidal thoughts, hostility and agitation.
Pfizer has asked the FDA to remove the black box, saying its own studies show no association between Chantix and severe psychiatric side effects. In October an FDA advisory committee recommended keeping the black box pending the outcome of an ongoing safety study.
Boxed warnings are reserved for the most serious of risks.
The FDA said recently it had examined a variety of studies, including analyses conducted by Pfizer. The studies had limitations that prevented the agency from drawing reliable conclusions.