Report: Pfizer Failed to Test Anti-Smoking Drug Chantix on Mentally Ill
Posted by Emily Rand
Pfizer Inc., the pharmaceutical giant that makes the smoking cessation drug Chantix, failed to test the drug on the mentally ill or those with a recent history of depression, according to a new report by Fairwarning.org.
Chantix, which helps smokers quit by suppressing the effects of nicotine on the brain, has been linked to suicidal behavior and other psychotic problems. By mid-2009, the U.S. Food and Drug Administration had received reports of nearly 100 suicides and 200 attempted suicides linked to Chantix.
The Fairwarning investigation also found that "FDA regulators approved Chantix after a speeded-up 'priority review' process, and did not request a follow-up study on mentally ill patients using the medication, even though the agency's own safety reviewer reported that the exclusion of such smokers may have undermined the clinical trials."