Everyone knows that smoking harms health and that the habit is difficult to quit. Unfortunately, some products that help people stop smoking can also be harmful.
On July 1, 2009, the U.S. Food and Drug Administration (FDA) announced that it would require pharmaceutical giants Pfizer and GlaxoSmithKline to include “black box” warning labels on their stop-smoking drugs, Chantix and Zyban. A “black box” warning is the FDA’s most serious caution, and indicates that a drug carries significant health risks. Chantix and Zyban now carry black box warnings that advise consumers of the mental health risks associated with their use, which can include changes in behavior, depressed mood, hostility, and suicidal thoughts.
These warnings were recommended as the result of a series of reports to the FDA’s Adverse Event Reporting System, as well as information gathered from clinical trials. Analysis of this information shows that some people who used Chantix and Zyban began experiencing changes in behavior, depressed mood, and suicidal thoughts shortly after starting the medication. The symptoms usually ended shortly after the medication was stopped, but some people still reported symptoms after stopping the medications, while still others did not even begin developing the symptoms until after they stopped taking the drug.
Neither of the drugs contains nicotine, unlike other smoking cessation aids such as chewing gum and the patch. Nicotine withdrawal can also cause mental health issues similar to those caused by Chantix and Zyban, such as depression, anxiety, irritability, restlessness, and sleep disturbance.
1 However, the mental health effects of these two drugs is not only caused by nicotine withdrawal. In fact, Zyban is another name for Wellbutrin, an anti-depressant.
Smokers who took Wellbutrin for depression found that it decreased the desire to smoke. GlaxoSmithKline responded by doing research that enabled them to sell the same product under a different name as a medication to be used to quit smoking. However, like most anti-depressants in the same class (known as SSRIs), the pills can cause an increase in suicidal thoughts. Wellbutrin and its generic counterparts already carry similar warnings, as do other SSRIs.
The question is whether the risks of taking one of these drugs outweigh the benefits. Quitting smoking is usually a step towards positive physical health, but doing so at the risk of damaging mental health is not a very good compromise. Instead, there are other, pharmaceutical-free ways to quit smoking that can be a first step towards good physical and mental health.
The mental health of anyone taking Chantix or Zyban should be closely monitored by a health care professional. Additionally, if you or someone you know is trying to quit smoking, be aware of the symptoms associated with quitting, and if symptoms develop, a health care professional should be contacted.
The black box warning is long, and starts with the following statements (from the product Web sites):
Zyban:
Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking ZYBAN for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking ZYBAN who continued to smoke.
Chantix:
Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family, or caregiver notice agitation, hostility, depression, or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia, or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.
1. U.S. Food and Drug Administration. "Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban." Press release. FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban. 1 July 2009. 10 July 2009
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm.
