Chantix Adverse Events Reportedly Underestimated Because of Weaknesses in Reporting Process


January 17, 2012

While the drug Chantix, Pfizer’s smoking cessation drug, has previously been linked to reports of incidents of violence and suicide, the prevalence of the problem may have been vastly underreported according to the Institute for Safe Medicine Practices, a non-profit drug company watchdog organization. While the serious adverse events were previously reported, they were reported according to procedures that permitted them to be hidden amongst minor adverse reactions. Pfizer reported hundreds of serious adverse reactions to the FDA through a process that lumped the serious adverse events in with reports of 26,000 minor adverse reactions.

The serious adverse events, including 150 suicides, were reportedly buried amidst reports of minor adverse events, such as minor skin irritations. The FDA procedure for reporting serious adverse events involves use of an expedited reporting system and must be reported within 15 days of the incident as opposed to the reporting system for minor adverse reactions that are reported collectively at the end of a quarter. Prior to July of 2010, there had been a total of 126 suicides reportedly linked to Chantax, which means the new spate of reported suicides doubled the total previously linked to use of the drug prior to July 2010.

This new revelation exposes a serious weakness in the FDA reporting system that may lead to other cases of underestimating the scope of serious adverse reaction. The study of the lumped together adverse events also included reports of other serious adverse results including 56 cases of possible psychosis, 156 reports of depression and 102 cases of aggression. Despite this research exposing almost 600 serious adverse results that were effectively hidden amongst non-serious reactions, Pfizer technically did not violate any law. The FDA does not require that death and serious adverse events be reported through the expedited system unless there are no prior reports of such adverse events.

While the FDA is considering closing this loophole in the reporting system, the change was first proposed in 2003 but has not been amended. The underreporting of serious adverse events may create a false sense of security. Chantax does carry a black box warning that includes the risk of suicide. The FDA has also ordered more clinical testing of Chantax dating back to 2009.

If you or someone you love has suffered a serious adverse event that you believe may be linked to your use of Chantax, you may be able to seek financial compensation. The Georgia defective drug attorneys at Montlick and Associates represents clients injured by defective drugs throughout the State of Georgia. Our Georgia defective drug lawyers are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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