Study Links Chantix to Suicide Risk, but FDA Disagrees
Researchers Say Anti-Smoking Drug Is Linked to Risk of Suicide; FDA and Drugmaker Disagree
FDA Perspective continued...
The warning states that some people have experienced "changes in behavior, hostility, agitation, depressed mood and suicidal thoughts or actions."
Riley says the researchers failed to consider the impact of media reports linking Chantix to suicidal behaviors as early as 2007, and how that might have influenced people's reporting of similar events after this time.
Moore denies this, countering that the FDA studies were "fatally flawed" in part because they relied on hospitalization records.
"Suicide does not result in hospitalization," he says.
Under the direction of the FDA, Pfizer is conducting a new clinical trial specifically designed to examine depression and other psychiatric events in Chantix users compared to users of Zyban, nicotine replacement, and placebo in people with and without prior psychiatric problems.
Results from the study are expected to be made public in 2017.
In a written statement, Pfizer spokesman MacKay Jimeson was highly critical of the reliance of Moore and colleagues on reports that came out after the drug went to market.
"Post-marketing reports can come from any source ranging from patients to health care providers, and from phone calls to Internet postings and lawyers," he tells WebMD. "Because of the many limitations of post-marketing reports, the conclusions made by the authors are not supported by the data."