FDA warns of dangerous side effects of smoking cessation drugs

Consumer Reports News: July 01, 2009 07:21 PM

The Food and Drug Administration today said smoking cessation drugs varenicline (Chantix) and bupropion (Zyban and generics) must now carry a "black box" warning that they can increase the risk of psychological side effects. These include unusual changes in behavior, hostility, agitation, depressed mood, suicidal thoughts, and attempted suicide.

People who are taking Chantix or Zyban and "experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their health-care professional right away," the FDA says. Additionally, if friends and family members notice these behavioral changes, they should counsel the person to stop taking the drug and call his or her doctor.

The FDA said it detected the increased risk for the side effects from reviewing reports of adverse events associated with the drugs.

The news about Chantix is not surprising. We first reported on potential serious side effects from Chantix, including aggressive behavior and suicide, more than a year ago. Bupropion was originally approved as an antidepressant (Wellbutrin and generic), and there have been some concerns about potential risks from that drug. But FDA officials said they included bupropion in the review, along with nicotine replacement therapies, to determine if reports of adverse events for Chantix were unusually high.

They concluded that the two drugs had similar rates of adverse events. According to the FDA, there have been about 188 reports of patients using Chantix who have attempted suicide, and 98 completed suicides. For bupropion, there have been 17 reported attempts at suicide, and 14 completed suicides. But these figures are rough and do not give an idea of the overall rates of such events. FDA officials did not see the same side effects with nicotine replacement therapies, such as nicotine patches.

The FDA also ordered the manufacturers of the drugs to conduct clinical trials to gauge the risk in the general population, as well as in those with mental illness. It’s currently unknown if these side effects are more likely to be seen in those with a history of depression or mental illness.

The "black box" warning means that the makers of these drugs must list side effects in any advertising and will not be able to air "reminder ads," which highlight a drug’s name but don’t mention the condition it treats. The warning won’t have an effect on "help-seeking ads," which mention a condition, but not drug names—like the one we dissected in the AdWatch video to your right.

CR’s Take: We recommend talking to your doctor to choose the best drug therapy to help you quit smoking. There are a number of time-tested treatments that can be effective, including nicotine replacement therapies. Chantix and bupropion may be effective, but you might want to try safer alternatives first. If you do use these treatments, make sure you are aware of the warning signs and are monitored closely for side effects.

Kevin McCarthy, associate editor

Read more tips on how to quit smoking, and see our Treatment Ratings (subscribers only) for more on nicotine replacement therapies and what works best in helping you quit.

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