Smoking Cessation Drugs Get Boxed Warning

Article excerpt

Accumulating reports of serious neuropsychiatric symptoms associated with the smoking cessation medications varenicline and bupropion have prompted the Food and Drug Administration to require new boxed warnings for the drugs.

The warnings, which went into effect July 1. highlight symptoms that include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and suicide.

The manufacturers also are required to revise the plain-language medication guides that come with the drugs.

The requirements will affect the drugs that are specifically indicated for smoking cessation--Chantix (varenicline), manufactured by Pfizer Inc., and Zyban (bupropion), manufactured by GlaxoSmithKline--as well as the generic and branded formulations of bupropion (Wellbutrin, Aplenzin) that already carry a boxed warning about the risk of suicidal thinking and behavior in the treatment of psychiatric disorders.

The FDA previously informed the public about the possibility of serious neuropsychiatric symptoms with varenicline in November 2007, and later issued a public health advisory in February 2008.

However, the new cases involving Zyban took the agency by "surprise," Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II at the FDA's Center for Drug Evaluation and Research, said in a press telebriefing.

Dr. Rosebraugh said symptoms "have occurred in patients with and without a history of psychiatric illness. …