Warnings on Smoking Cessation Drugs

On July 1, 2009, the US Food and Drug Administration (FDA) announced the popular smoking-cessation drugs varenicline (Chantix, by Pfizer) and bupropion (Zyban, by GlaxoSmithKline) must carry a “boxed warning” for physicians because these medicines have been associated with serious mental health events. Similar warnings will also be required for bupropion marketed as Wellbutrin, and for generic versions of bupropion.

These new warnings are based on reviews of postmarketing adverse event reports for the drugs, specifically suicides and suicidal attempts. With both medicines, there has been “observations of a temporal link between use of the drugs and either suicidal events or the occurrence of suicidal ideation and suicidal behavior in patients who had no history of psychiatric illness,” according to Curtis Rosebraugh, M.D., director of the FDA’s Office of Drug Evaluation II.

These symptoms have occurred in those with and without previous psychiatric illness, tend to occur shortly after the patient starts the medicine, and usually end once the medicine is stopped. The FDA is requiring the two pharmaceutical companies to conduct further tests on this issue because the current numbers come from crude reporting data and have not been verified. Some symptoms could be related to nicotine withdrawal.

Both drugs have been shown to be effective at helping patients quit smoking, and Dr. Rosebraugh indicated the FDA is not advising against their use for that purpose, nor is their use contraindicated in any specific patient population.

If patients report experiencing agitation, depressed mood, changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior, the FDA recommends that clinicians advise patients to stop taking varenicline or bupropion immediately. Monitoring such patients should be continued until the symptoms have stopped.

Any adverse events associated with varenicline or bupropion should be communicated to the FDA’s MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.