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."
Despite the findings, Pfizer told Fairwarning they "acted responsibly and appropriately at all times in connection with the development, approval, and marketing" of Chantix.
The FDA also says it acted properly in approving the drug. "The agency does not feel any mistakes were made," FDA spokeswoman Sandy Walsh told Fairwarning "We can never speculate as to what may happen with a drug once it goes into widespread use after approval."
In June 2009, the FDA required a black box warning---its strongest alert---be added to Chantix packaging.
"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research said at the time.