Chantix

About Chantix

Chantix, also known as Varenicline, is a prescription drug used to assist individuals who are attempting to quit smoking. Chantix works in the brain to block the pleasurable effects of smoking. Chantix is manufactured by Pfizer, and received FDA approval for national use in May 2006.   Chantix was given “priority review” by the FDA, due to its apparent efficacy during trials, and the perceived lack of health risks posed by the use of the drug.

However, within a short time after the approval of Chantix, there were reports of severe side effects and reports of individuals committing suicide as a result of taking the drug. Due to reports of adverse side effects, in February 2008, the FDA issued an alert to warn physicians and patients of the potential link between Chantix use and psychiatric side effects. This alert was further strengthened in mid-2009 when the FDA issued an order requiring Chantix to have a black box label, warning consumers of the potential for depression, and suicidal ideations and actions.

This black box warning came on the heels of the FDA analysis of adverse side effects reported from use of Chantix in the second-half of 2008; in that time period, 910 individuals reported serious injury from the use of Chantix, including thirty-eight deaths. Serious neuropsychiatric symptoms occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. Despite these serious risks, to date, the FDA has not recalled Chantix.

Conditions Caused By Chantix

Side Effects & Symptoms

Warnings & Recalls

• In February 2008, the FDA issued an alert warning of a potential link between Chantix use and adverse psychological reactions.
• In July 2009, the FDA issued an order requiring Chantix to carry a black box label, warning consumers of the increased risk of depression, suicidal ideation and actions when using Chantix.  A black box warning is the most serious safety warning available from the FDA.
• Thousands of cases of patients suffering adverse effects from Chantix have been reported to the FDA since 2008.

Cases, Settlements, & Verdicts

All lawsuits filed in federal court against Pfizer over alleged side effects of Chantix, their popular smoking cessation treatment, have been centralized for pretrial litigation before U.S. District Judge Inge Prytz Johnson in the U.S. District Court for the Northern District of Alabama as part of a multidistrict litigation (MDL). The cases involve similar allegations that Pfizer failed to adequately research their medication or warn about the risk of suicide from Chantix or other psychological side effects.

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