July 1, 2009 -- The FDA warns that bizarre behavior -- including suicide -- is seen in people taking the stop-smoking drugs Chantix and Zyban.
Both drugs now will carry "black box" labels warning that people taking the drugs should be closely watched for signs of suicidal thoughts, depression, hostility, or other changes in behavior.
"We want people to use these drugs carefully and pay attention," Robert J. Temple, MD, director of the FDA's office of medical policy, said at a news conference. "Stopping smoking is a goal we all want to work toward. We don't want to scare people off these drugs -- we just want them carefully monitored."
It's not at all clear that the drugs actually cause these behavior changes. Smokers are addicted to nicotine -- and when they quit, their withdrawal symptoms can include many bizarre behaviors, including suicide.
However, Curt Rosebraugh, MD, MPH, director of one of the FDA's drug evaluation units, said that some of the suicide reports came from Chantix users who were still smoking.