Federal drug regulators warned Wednesday that patients taking two popular drugs to stop smoking should be watched closely for signs of serious mental illness, as reports mount of suicides among the drugs’ users, The New York Times reports.
The U.S. Food and Drug Administration said it will immediately require boxed warnings about the risk of serious neuropsychiatric symptoms on the packaging of two popular smoking cessation drugs -- varenicline (Chantix) and buproprion (Zyban, Wellbutrin and generics).
Reports of behavioral changes, depressed mood, agitation, hostility and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA's adverse event reporting system, ABC News reports.
Commenting on this Robert J. Temple, MD, director of the FDA's office of medical policy, said at a news conference: "We want people to use these drugs carefully and pay attention. 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," WebMD reports.
But despite the stricter warnings, the FDA said consumers and doctors have to weigh the benefit versus the risks of the drugs.
"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," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, The Chicago Tribune reports.