FDA Advisory Committee Votes to Retain Black Box Warning for Chantix

Posted by The Evidence Blog on October 27, 2014

The warning for patients taking Chantix (varenicline; Pfizer Inc.) should remain on the drug label until data from a randomized controlled trial that is currently underway are available for evaluation. The black box warning is intended to alert the patient and provider to the risk of adverse neuropsychiatric events, including suicidal thoughts and behavior, associated with Chantix.

Chantix is indicated for use as an aid to smoking cessation. The current black box warning instructs patients that serious neuropsychiatric events have been reported in people taking Chantix. It advises patients to stop taking Chantix and contact a healthcare provider immediately if they experience agitation, hostility, depressed mood, or changes in behavior or thinking that is not typical, or if the patient develops suicidal ideation or suicidal behavior.

Members of the Food and Drug Association (FDA) Psychopharmacology Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee were convened as a result of a request by Pfizer that the FDA remove the current black box warning for Chantix. The combined committee reviewed materials presented by Pfizer, including observational studies and recent meta-analyses of prior randomized controlled trials. Of the 18 committee members, 11 voted to retain the black box warning as it currently exists; 6 recommended revision of the warning, and 1 voted to remove the warning completely.

A phase IV, randomized, double-blind, active and placebo-controlled, multicenter study evaluating the neuropsychiatric safety and efficacy of Chantix and bupropion (EAGLES trial; NCT01456936) is underway; it is projected that data from this trial will be available in late 2015. The FDA Advisory Committee noted that a change in labeling should not be considered until data from this trial are available for consideration.

For more information, refer to the Hayes Medical Technology Directory report, Smoking Cessation in Patients with Schizophrenia.

Topics: Hayes Blog

Sign up to receive updates from our blog

Our latest articles

New Call-to-action