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News » 2009 » August » Nicotine-replacement therapies can cause psychiatric diseases

Nicotine-replacement therapies can cause psychiatric diseases


The Food and Drug Administration (FDA) issued a public warning, stating that leading smoking cessation medications can cause severe mental diseases as adverse effects. The doctors should warn their patients about serious side effects while administering Chantix or Zyban as part of smoking cessation therapy.

The FDA issued the warning after completing receiving numerous reports of mental health disorders including suicidal thoughts, visual and hearing impairments among the patients who have been taking Chantix, produced by Pfizer, and GlaxoSmithKine’s Zyban.

Both of the medications would now have to place special warnings, called “black box” labels. The FDA experts strongly recommend patients using these drugs to visit their physicians more frequently in order to be monitored for symptoms of any behavioral alterations like depression, hostility, etc.

Moreover, the manufacturers of both medications will be obliged to perform clinical examinations in order to estimate mental health dangers related to the consumption of both medications. In contrast to the examinations performed by the FDA, the latest tests would include smokers inclined to mental disorders. Pfizer spokesman said the company already started checking schizophrenia patients as part of the clinical examinations.

According to the adverse effects’ reports, collected by the FDA, since the approval of both drugs, there were registered almost 100 suicides and 190 attempts to commit a suicide among the users of Chantix, whereas similar rates among the consumers of Zyban showed 15 suicides and 17 attempts.

Yet, the FDA authorities state that such adverse effects should not prevent smokers from trying those nicotine-replacements drugs, because smoking carries much more health hazards than the medications.

Chantix was initially introduced to the market in 2006. It was considered as the most effective smoking cessation therapy and was administered to 90 percent of all patients, said the spokesman for IMS Health, company specializing in health care reports and researches. But in 2008 the sales of Chantix dropped dramatically due to the concerns about severe adverse effects, including temporary psychiatric disorders. Experts do not expect the recent FDA warning to effect future sales due to the fact that the majority of patients and potential quitters have already been aware of possible adverse effects by previous warning labels.

At the same time, Dr. Steve Romano, vice chairman of Pfizer stressed that nicotine cravings are very difficult to overcome for many people, and therefore, the smokers who have been trying to give up are already exposed to stress and depression, making it very complicated to single out particular effect of the medications. As regards the strict warnings, Dr. Romano mentioned that the major aim of the warnings was to stress the necessity for physicians to pay more attention to psychical state of the potential quitters and tell people what they should be aware of.