Study examines reports of aggression for patients on Pfizer’s Chantix

A 47-year-old woman started hitting her daughters and yelled at them after leaving the room. She then shot herself to death - all a month after she began taking Chantix to quit smoking, according to a report to the Food and Drug Administration.

A 27-year-old man became aggressive and displayed odd behavior four days into taking the anti-smoking drug, also known generically as varenicline. He then attempted suicide with a shotgun, but survived, marking another report linking aggressive behavior to the medication.


And in yet another report to the FDA, a 21-year-old woman who had been taking Chantix for two weeks threatened her mother with a shotgun and locked herself in a bathroom.

These and 23 other reports involving aggressive behavior were analyzed by three researchers for the September issue of the Annals of Pharmacotherapy published online on July 20. The researchers, including Thomas J. Moore of the Institute for Safe Medication Practices in Horsham, Pa., a Harvard University doctor, and a professor from Wake Forest University, examined 26 case reports of such incidents, culled from 78 FDA reports and other published reports involving patients taking Pfizer’s anti-smoking drug.

The selected cases involved 10 assaults, nine instances with homicidal ideation, and seven patients who acted or thought about committing acts of aggression or violence. Most of the cases reviewed were unprovoked, with the target of the aggression being anyone near the patient, and involved someone with no history of such behavior.

“The clear temporal relationship, lack of prior history of this behavior, and unusual nature of these events strengthens the accumulating scientific evidence that varenicline is associated with thoughts and acts of aggression/violence,” the researchers concluded. “All patients should be advised to contact a health-care provider immediately if these symptoms occur and varenicline should be discontinued without delay.”

The FDA approved Chantix for sale in the U.S. as a smoking cessation aid in May 2006. Since then ithas added two public health advisories and required a “boxed warning” on the product.

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