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Judge Rules Chantix Black Box Warning is Strong Enough


July 25, 2012 — A federal judge in Alabama has ruled that the Black Box warning on Pfizer’s anti-smoking drug Chantix (varenicline) is strong enough to warn people about the risk of suicidal thoughts. The implication of the judge’s ruling is that Pfizer may escape an expensive, extended multidistrict litigation from plaintiffs alleging the company failed to warn about the risk of suicidal ideation after 2009.

Pfizer faces thousands of lawsuits from people who argue that the Black Box warning imposed in July 2009 did not adequately warn about the risk of suicidal thoughts. Many of the plaintiffs are family members of people committed suicide or attempted suicide while taking the drug. Chantix has also been linked to sudden aggressive behaviors.

Soon after Chantix was approved in 2006, the FDA began receiving reports of people who suffered unusual suicidal behaviors after taking the drug. Chantix works by suppressing the positive emotional response people get when they smoke cigarettes, but it can also negatively impact emotion when the person is not smoking cigarettes. Pfizer voluntarily made minor updates to the label, but the FDA forced Pfizer to place a Black Box on the label in 2009. The Black Box is the strongest warning that the FDA can place on the label of a drug.

Many lawsuits were filed by people after Pfizer added that Black Box warning, and Pfizer has asked that those cases be dismissed. The judge partially granted and partally denied Pfizer’s motion. Although the judge determined that the Black Box warning was sufficient, Pfizer must file individual summary judgment motions in each case.

As of July 24, 2012, there are 2,627 Chantix lawsuits pending in the multidistrict litigation. Most of those cases involve people who were injured before the Black Box warning was added. Attorneys for both parties are currently building their cases, and the first trial is set to begin on October 22, 2012.

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