FDA Removes Black Box Warning from Varenicline's Label

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The FDA has agreed to remove the black box warning from the label of the smoking-cessation drug, varenicline (Chantix). The warning alerted patients about the risk for serious neuropsychiatric events like depression and suicidality.

Additionally, the agency is updating the boxed warning for bupropion (Zyban). Language about serious neuropsychiatric effects seen in patients quitting smoking will be removed.

The FDA notes that while the labels for both drugs will still warn about the possibility of serious side effects on behavior and mood, these risks are "lower than previously suspected." The decision is based in part on data from a smoking cessation trial of some 8000 patients, both with and without a history of psychiatric conditions.

This past September, an advisory panel voted 10-9 in support of removing the black-box warning from varenicline. It was originally added by the agency in 2009.