The U.S. Food and Drug Administration (FDA) said Wednesday it will require two smoking-cessation drugs—Chantix and Zyban—to carry the agency's strongest safety warning over side effects including depressing and suicidal thoughts. The new requirement is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs. The FDA also is requiring an additional study on Chantix and Zyban to determine the extent of the side effects. The anti-depressant Welbutrin, which has the same active ingredient as Zyban, already carries such a warning. Pfizer Incorporated, which makes Chantix, already had updated its labeling following the initiation of an FDA investigation into the possible side effects in 2007. “The risk of serious adverse evens while taking these products must be weighed against the significant health benefits of quitting smoking,” said Dr. Janet Woodcock, the 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.”
