Last week, the U.S. Food and Drug Administration (FDA) announced that it is requiring manufacturers to put a boxed warning on the prescribing information for Chantix and Zyban, two prescription drugs used to help patients quit smoking.

The purpose of the warning is to highlight the risk of serious mental health effects, including depressed mood, hostility, suicidal thoughts, and other behavior changes, that may occur while taking these drugs.

In most patients who experienced these adverse events, the side effects began shortly after starting the smoking cessation drug and ended when the medication was stopped. However, some people continued to have symptoms even after stopping the medications. Although those who quit smoking may experience similar symptoms even if they are not taking either Chantix or Zyban, these mental health effects were also presorted in patients who were still smoking while taking these medications.

Smoking continues to be the leading cause of preventable disease, disability, and death in the United States. Both Chantix (varenicline) and Zyban (bupropion) are effective in helping people to quit the habit, but the risk of adverse events associated with these products needs to be weighed against the significant health benefits of quitting smoking. Health care professionals are cautioned to closely monitor their patients on Chantix or Zyban for changes in mood or behavior after starting these drugs. And, patients are advised to immediately contact their health care provider if they experience any side effects.

Source:

U.S. Food and Drug Administration News Release, July 1, 2009.