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Smoking-cessation drugs must carry Boxed Warning, FDA says


ROCKVILLE, Md. Two smoking-cessation drugs will require the highest possible warning label because of the risk of mental health problems in patients taking the drugs, the Food and Drug Administration announced Wednesday.

The FDA said that Pfizer’s Chantix (varenicline) and GlaxoSmithKline’s Zyban (bupropion) will carry so-called Boxed Warnings to highlight the risk of changes in behavior, depression, hostility and suicidal thoughts.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “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.”

Chantix has come under increased scrutiny due to its mental health side effects. Amid reports of the side effects by the FDA last May, the Federal Aviation Administration banned the use of Chantix by pilots, while officials at a U.S. military base in Okinawa, Japan, pulled it from the shelves of the base’s pharmacy in August, though it remained available in the hospital.

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