Chantix Anti-Smoking Drug Gets Stronger Warning

February 2008

UPDATE – The U.S. Food and Drug Administration (FDA) has reported that the link between Pfizer’s anti-smoking drug Chantix and serious psychiatric problems in users of the drug is “increasingly likely.” The FDA has received reports of 37 suicides and more than 400 instances of suicidal behavior in connection with the medication.

This comes two weeks after Pfizer added stronger warning labels to Chantix. At the time, Pfizer said that instances of suicidal behavior could be linked to the effects of nicotine withdrawal and not the drug itself. However, the FDA reports that psychiatric problems have been found in Chantix patients who are still smoking, strengthening the causal link between the drug and suicidal behavior.

In a public advisory released Friday, February 1, the FDA said patients taking Chantix should tell their doctor about any history of mental illness. Additionally, family members and friends should look for any changes in mood or behavior.

January 2008

ORIGINAL ALERT – Trying to quit smoking? Be aware that Pfizer, Inc. has issued stronger warnings about its anti-smoking drug Chantix. Instances of depression, agitation, suicidal thinking, and suicidal behavior have been reported among some users of Chantix, and doctors are being asked to closely monitor this behavior.

The serious nature of these side effects has prompted Pfizer to strengthen the language of a previous warning and feature it more prominently on the drug’s label. The U.S. Food and Drug Administration has been reviewing the safety of Chantix since last November.

Chantix is used by more than five million patients. The drug first came under widespread public scrutiny after family members of a prominent Dallas musician claimed Chantix may have caused the rage that led him to be shot and killed after kicking down a neighbor’s door.