After receiving dozens of traffic accident reports involving Chantix users, the Food & Drug Administration (FDA) is reviewing the drug again to see if the safety information on its label is adequate.

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.

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.  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.

A previous report issued by the Institute in May also found that the FDA had received dozens of traffic accident reports involving Chantix  in the final quarter of 2007. 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.

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.