Stop-Smoking Drug Chantix Back Under FDA Scrutiny

Chantix, the popular smoking cessation drug already linked to suicidal behavior and terrifying nightmares, is again being investigated by the Food and Drug Administration, this time for causing blackouts, vision problems, and other serious side effects.

The Pfizer drug, approved in 2006 and taken twice daily in pill form, appears on an updated FDA list of drugs currently under review for possible safety problems. The list was just updated today to include Chantix and 19 other drugs.

Chantix has been under close scrutiny since 2007, when the FDA started hearing from people who took the drug and developed suicidal tendencies, aggressive behavior, depression, and other serious symptoms. Pfizer updated Chantix’s labeling to warn users of the risks and cautioned that people taking the drug to kick their smoking habits should be closely monitored for odd behavior.

Also, the Federal Aviation Administration and the National Transportation Safety Board ordered pilots, air traffic controllers, and long-haul truckers not to take Chantix during or immediately before their shifts, since the drug might cause vivid hallucinations and aggressive behavior that could lead to deadly accidents.

Chantix’s labeling already warns against operating heavy machinery while on the drug. Champix, the name of the same drug as it is sold in Canada, also has been associated with severe psychiatric symptoms.

In the fall of 2008, the FDA started investigating reports of blackouts, impaired vision, and other problems in people taking Chantix. According to one non-profit group monitoring the drug, there were more than 1,000 reports to the FDA of serious injuries over just a three-month period in 2008.

Chantix has become one of Pfizer’s best-selling drugs, earning the company about $846 million in sales in 2008, officials said. The drug works by attaching to nicotine receptors in the brain to block the pleasurable effects of nicotine, helping smokers quit.

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