December 31st, 2007
Chantix, an anti-smoking medication, continues to be touted as a “wonder drug” by its maker, Pfizer, Inc., despite the fact that it has been linked to 63 deaths and thousands of reports of psychiatric symptoms in the Unites States and Great Britain in the past year. Yet even though the US Food & Drug Administration (FDA) recently issued a warning about serious Chantix side effects, the dangerous medication is still being aggressively marketed with a campaign that features slickly produced TV commercials that make no mention of Chantix’s potential problems.
Chantix, approved in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. The Chantix label warns of various side effects, including nausea, changes in dreaming, constipation, gas and vomiting. But those warnings are more prominent and easier to find than the fine print on the package insert that warns of the possibility of psychotic and suicidal behavior.
In November, the FDA said that it was beginning a safety review of Chantix after it received reports of 55 suicides and 199 suicidal thoughts possibly linked to Chantix use. The FDA said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking. At that time, the FDA recommended that doctors monitor patients taking Chantix for behavior and mood changes.
Similar problems with Chantix have also been reported in Britain, where the drug hit the market a year ago under the name Champix. The UK’s Medicines and Healthcare products Regulatory Agency, had received 1335 reports of patents suffering serious side effects, including seven deaths — one of which was a suicide — by December 18. Chantix was also linked to 748 cases of psychiatric problems including suicidal thoughts and depression, 819 gastrointestinal disorders and 70 heart disorders.
But smokers encouraged to ask their doctors about Chantix after seeing one of Pfizer’s engaging TV commercials or viewing its Chantix website would not know of the drug’s potential for psychiatric side effects. The side effects section of the Chantix website lists what Pfizer calls the drug’s “most common” side effects – nausea, sleep disturbance (trouble sleeping, changes in dreaming), constipation, gas, and vomiting – but makes no mention of suicide or suicidal thoughts. The website only warns that “These are not all the side effects of Chantix. Ask your doctor or pharmacist for more information. ” But even the site’s section aimed at healthcare professionals makes no mention of suicide, suicidal thoughts or psychiatric side effects.
The FDA is expected to take several months to complete its Chantix safety review. While that review is ongoing, many people will continue to use Chantix, possibly unaware of its potential to cause dangerous psychiatric side effects.