"The labeling update underscores the important role of health-care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely," Dr. Briggs W. Morrison, senior vice president for the Primary Care Development Group at Pfizer, said in a prepared statement. "Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex."
The FDA's review of consumers using nicotine patches did not find a link between patches and psychiatric side effects.
The antidepressant Wellbutrin, which contains the same active ingredient as Zyban, already carries a black-box warning.
For more on how to quit smoking, visit the U.S. Centers for Disease Control and Prevention.
SOURCE: July 1, 2009, teleconference with Curt Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, U.S. Food and Drug Administration