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FDA concerns over Chantix, an anti-smoking drug, continue

Chantix was among the 20 medications under investigation for potential safety issues, according to an updated list from the Food and Drug Administration released on June 4, 2009.

Chantix, a twice daily pill, eases nicotine withdrawal symptoms by blocking the pleasurable effects of nicotine. Chantix is manufactured by Pfizer of New York. Approved in May 2006, Chantix quickly became one of the fastest growing products on Pfizer’s balance sheet, though sales fell 4 percent in 2008 to $846 million.

The FDA is investigating reports of injury, visual impairment and other problems connected with Chantix, which is designed to help smokers quit. In 2008, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams.

Regulators first began investigating Chantix in 2007 after receiving several reports of psychiatric problems, including suicidal thoughts. That prompted Pfizer to update the drug’s labeling that patients should be monitored for unusual behavior.

Institute for Save Medical Practices, a nonprofit group, highlighted 1,001 reports to the FDA of serious injuries linked to the drug over a three-month period, more than for the 10 best-selling brand name drugs combined.

ISMP found 15 cases of Chantix patients involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA said it taking a second look at the Chantix warnings.

Pfizer said at the time that the high number of reports might be linked to greater publicity about the side effects. It also contends that the drug’s benefits clearly outweigh its risks. “We stand by the efficacy and safety profile of Chantix,” the company said in a statement. “There are few things that provide greater health benefits than quitting smoking. Pfizer is committed to reducing the prevalence of smoking globally. As part of that mission, we want to increase peoples’ understanding of the dangers of smoking and the benefits of quitting.”

The Federal Aviation Administration has banned use of Chantix by pilots and air traffic controllers.

While the current label cautions that patients should not drive or operate heavy machinery, this language is standard for many medications.

Reports of adverse events associated with Chantix should be reported to the FDA.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049088.htm

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