Boxed warning required for Chantix and Zyban, says FDA

Smoking cessation drugs Chantix and Zyban are causing unusual changes in behavior, depression, and suicidal thinking in those who have taken these drugs to quit their smoking habits.

The U.S. Food and Drug Administration is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion).

The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, 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.”

Similar information on mental health events will be required for bupropion marketed as the antidepressant Wellbutrin and for generic versions of bupropion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

It is advised that health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs.

Patients should immediately contact their health care professional if they experience such changes.

Chantix is manufactured by New York based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

Source: U.S. Food and Drug Administration, USA



Leave a Comment

Health Newstrack