Anti-Smoking Drugs Chantix and Zyban Get Black Box Warning About Risk of Suicide and Mental Illness

By July 7, 2009Dangerous Drugs

The U.S. Food and Drug Administration announced July 1 that it would require the strongest safety warning possible on the labels of prescription smoking cessation drugs Chantix (varenicline) and Zyban (bupropion, also sold as Wellbutrin), the Washington Post’s The Checkup blog said July 1. Both are sold to people who are trying to quit smoking, but have come under fire as users and scientists began to discover serious psychiatric side effects. The black box warning will tell patients that the drugs carry an increased risk of depression, hostility, mood changes and suicidal thoughts. Manufacturers Pfizer (Chantix) and GlaxoSmithKline (Zyban) are also required to run new clinical trials examining how often these mental health problems occur in users.
The move came after multiple reports of depression, increased depression and other behavioral changes that started shortly after taking the drug and stopped shortly after discontinuing use. An FDA newsletter said it received 153 reports of suicidal “adverse events” for Chantix and 75 for Zyban since their approval for use as anti-smoking drugs. This was true at the recommended dose, for people both with and without a previous history of depression. However, the FDA noted that some of these side effects may also be associated with nicotine withdrawal. It also told users not to stop the drugs cold turkey, since this can cause side effects and smoking is a serious health risk — just to be aware of the risk and talk to their doctors about problems.
I’m sorry to say that this is not the first report of mental health side effects I’ve seen as a dangerous drug attorney. Chantix in particular (called Champix overseas) has been under investigation since 2007, shortly after its fast-tracked approval the year before. In addition to depression and suicidal thoughts, Chantix users have reported agitation, aggression, homicidal thoughts, bizarre dreams and psychosis. Zyban users have reported similar problems, including hallucinations — and when it is sold as Wellbutrin, bupropion already carries a black box warning about suicide.
The FDA’s action doesn’t take these drugs off the market, but the black box requirement is a powerful warning to consumers that they should be use caution. As a defective drug lawyer, I have seen several accounts of people who suffered serious psychiatric changes after starting one of these quit-smoking drugs, most recently a Pennsylvania man who said taking Chantix might have something to do with his attack on his wife. Like all manufacturers, drug makers have a legal responsibility to offer us products that are safe and free of defects. When they fail, consumers who are hurt can hold them legally and financially responsible for the results. If it becomes clear that Pfizer and GlaxoSmithKline were selling drugs without a clearly necessary warning — or even knew of the side effects ahead of time — they could be hit with multiple pharmaceutical injury lawsuits.


If you or a loved one has been hurt by taking a prescription drug that was supposed to help, you should contact Carey, Danis & Lowe as soon as possible for help. Based in St. Louis and Belleville, Ill., we represent people from around the Midwest and the United States who developed life-altering side effects after taking a prescription drug they thought they could trust. A lawsuit can’t reverse the effects of a serious pharmaceutical injury, but it can help victims defray the enormous costs of treating those injuries, including future medical care and lost income from missing work. It can also win them compensation for a wrongful death, a permanent disability or other serious injury. And of course, an individual or class-action lawsuit can hold drug makers legally and financially responsible for their actions.
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