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Chantix Under Review by FDA After Traffic Accident Report

Oct 24, 2008 | Parker Waichman LLP Reports of traffic accidents by users have prompted federal regulators to take another look at the safety information on the Chantix label.  Word of the latest Food & Drug Administration (FDA) review comes just days after a non-profit drug research group released a report that found, in the first quarter of 2008,  the FDA received more serious side effect reports for Chantix than for any other medication.

According to the report issued Tuesday by the Institute for Safe Medicine Practices, the FDA received 1001 reports of serious adverse events associated with Chantix in the first three months of this year.  The only other drug that even came close to matching Chantix during the same period was heparin  (779 side effect reports, including 238 possible deaths), which was the subject of a drug contamination scandal earlier this year.

According to the Institute, the Chantix side effect reports included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.

This was the second report on Chantix side effects the Institute has issued this year.   In May, researchers there reported that Chantix had been the subject of   224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.

According to Reuters, the accident reports are being reviewed by the FDA. "FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate," an FDA spokesperson told Reuters via email.

The FDA has already reviewed Chantix for a possible link to suicide and suicidal behavior.  In February, the agency asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

Following the May report from the Institute for Safe Medicine Practices, several government agencies, including the Department of Transportation, the Federal Aviation Administration and the Department of Defense issued rules restricting the use of Chantix.

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