Pfizer Withheld Reports of Adverse Chantix Effects

Questions regarding the adverse psychiatric complications associated with Chantix have long gone unanswered in the healthcare community. However, recent findings add weight to the long-suspected link between Chantix and bouts of uncontrollable rage. It has been reported that Pfizer has failed to properly send hundreds of adverse event reports involving psychiatric problems with Chantix to the U.S. Food and Drug Administration (FDA). As a result, Chantix side effects have long been underestimated.

According to a quarterly report released by the Institute for Safe Medicine Practices (ISMP), Pfizer failed to properly report hundreds of serious psychiatric problems associated with Chantix since 2006. As staggering as these numbers are, they do not include the unreported incidences associated with the 150 Chantix related suicides in 2007. As a result of these misleading numbers, the ISMP is calling for an FDA investigation into Pfizer’s actions.

In the third quarter of 2010, the ISMP noticed a spike of 1,055 serious adverse events reported for Chantix. In the wake of these suspicious findings, the ISMP discovered 589 individual reports of dangerous and potentially fatal side effects that took place years ago, but had not been reported to the FDA’s Adverse Events Reporting System (AERS) until July 2010. Further inquiry by the ISMP divulged 589 reports from 2009 and early 2010, 176 reports from 2008, 119 reports from 2007 and 12 reports from 2006 that were delayed.

Including the delayed reports of adverse effects, these numbers are significantly larger than any other drug monitored by ISMP. The ISMP indicates that Chantix was associated with more suicides, more reports of depression, psychological side effects and violence than any other prescription drug. Among the recently identified adverse events were 150 Chantix suicide reports, which was more than two times the amount of suicides linked with Chantix use. The FDA was only aware of 122 reports of suicide submitted by Pfizer at the time.

Last year, the FDA had to send a stern warning letter to Pfizer saying that they had found numerous discrepancies in its compliance with adverse event reporting rules since 2004. Federal drug regulations state companies must file serious adverse event reports within 15 days of receiving them. The FDA announced that Pfizer had failed to submit serious reports, misclassified other reports and downgraded serious problems and filed them with non-serious reports.

When asked why Pfizer did not report the adverse health effects due to Chantix, the company responded with a refusal to answer, saying they may soon enter Chantix litigation.

Do I Have A Chantix Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Chantix lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one have been injured by Chantix, you should contact us immediately. You may be entitled to compensation and / or refund by participating in a Chantix lawsuit and we can help.