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March 10, 2015

U.S. FDA warns of seizure, alcohol risk with Pfizer's Chantix

Quoted from http://www.reuters.com/article/2015/03/09/us-pfizer-chantix-warning-idUSKBN0M527T20150309

U.S. FDA warns of seizure, alcohol risk with Pfizer's Chantix

Mon Mar 9, 2015  

(Reuters) - The U.S. Food and Drug Administration warned on Monday that Pfizer Inc's quit-smoking drug, Chantix, has been 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 September 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.

[Article continues at original source]

Posted at 08:26 AM in Chantix |

Tags: Chantix, drug injury, FDA warning, label change, Pfizer, seizures, side effects

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