FDA warns on 2 antismoking drugs

July 02, 2009|Associated Press

NEW YORK - The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts.

The new requirement, called a “black box’’ warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.

The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC’s Zyban, already carries such a warning.

The FDA is also requiring an additional study on Chantix and Zyban to determine the extent of the side effects. Pfizer Inc., which makes Chantix, said it is still discussing the potential study design with the FDA.

Pfizer had already updated its labeling in 2007 after the FDA began investigating the potential side effects. That investigation was sparked by reports of about 37 suicides and more than 400 reports of suicidal behavior in connection with the drug.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,’’ said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.’’