Cases Build for Chantix Suicides and Suicide Attempts, FDA Ups Warning

Shortly after Chantix was introduced, an alarming number of reports were received by the FDA MedWatch adverse event reporting system involving users who committed suicide on Chantix or suddenly attempted suicide, despite no prior history of psychological problems. In November 2007, the FDA issued an early communication regarding an emerging safety concern which linked the use of Chantix and suicide, suicidal thoughts and sudden changes in behavior. In February 2008, the FDA issued a statement which suggested that their evaluation indicates it is “increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” In July 2009, the FDA required Pfizer to add a prominently displayed boxed warning stating the possible side effects of Chantix including behavior changes, depression, hostility and suicidal thoughts, which is the
strongest warning that can be placed on a prescription medication.

As of recent data, Health Canada received over 1,200 reports of adverse reactions associated with Chantix since its release in country in 2007. The FDA first indicated that they were reviewing the side effects of Chantix in November 2007. In response, Pfizer updated the drug’s label, but provided vague and confusing indications about a connection between Chantix and suicide, suicidal thoughts and Chantix aggressive behavior, and mood swings.  Since that time the drug maker has made several other updates to the warning label, but the FDA’s actions yesterday make it clear that Pfizer has not done enough to protect the public from the Chantix dangers.

According to WebMD and Thomas J. Moore, senior scientist for drug safety and policy at the ISMP, that Chantix has so much potential danger it should contain restrictions including exclusions for police, military, and others who must carry weapons. Moore is one of three others who co-wrote the Chantix report published in the journal, Annals of Pharmacotherapy, said WebMD. In addition to this, new research suggests that side effects of Chantix could significantly increase the risk of heart attacks, strokes and other cardiovascular events; echoing concerns raised by the FDA in June. A number of Chantix lawsuits have been filed in courts throughout the United States on behalf of individuals who have died or suffered serious injuries as a result of a suicide or unusual behavior allegedly caused by Chantix.