FDA Highlights Emerging Safety Signal With Chantix

The FDA is notifying healthcare professionals about reported cases of suicidal thoughts and aggressive and erratic behavior in patients taking Pfizer’s new smoking cessation product Chantix.

In a MedWatch report issued Nov. 20, the agency asked healthcare providers to monitor patients on Chantix (varenicline) for behavior and mood changes.

A preliminary assessment of adverse event reports showed that many cases reflect new onset of depressed mood, suicidal thoughts and changes in emotions and behavior within days to weeks of initiating treatment with the drug.

“The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking,” the FDA said.

In addition, the agency is notifying physicians that reports of drowsiness in patients on the drug have been reported. Upon initiation of therapy, patients should use caution while driving or operating machinery until they know how the drug will affect them.