Judge Rules Chantix Black Box Warning is Strong Enough

July 25, 2012 — In response to a motion filed by Pfizer, an Alabama judge has determined that the Black Box warning placed on Pfizer’s anti-smoking drug Chantix was sufficient to warn people about the risk of suicidal thoughts and behavior.

It is good news for Pfizer, who faces thousands of lawsuits in federal court from people alleging the company failed to warn about the risk of suicide. The Black Box warning was added in 2009, and Pfizer may escape lawsuits from people who were injured by Chantix after that date.

Pfizer is currently facing 2,627 lawsuits in a federal multidistrict litigation. Most of the plaintiffs were injured after the drug was approved in 2006, but before the Black Box warning was added in 2009. Lawsuits have been filed by family members of people who used Chantix and committed suicide.

After Chantix was approved in 2006, people began reporting abnormal suicidal ideation, suicide attempts, and sudden aggressive behavior. Chantix targets a smoker’s pleasure response after they smoke a cigarette, but it can also affect other emotions. People who suffered these side effects allege that Pfizer failed to fully investigate the risk of suicidal behavior and failed to warn about the risk.

Pfizer made minor updates to the label until 2009, when the U.S. Food and Drug Administration (FDA) forced Pfizer to place a Black Box warning on the label. The FDA reserves the Black Box for lethal side effects, and it is the most serious warning that can be placed on a drug.

Pfizer has requested that lawsuits filed after 2009 should be dismissed. Although the judge agrees that the Black Box warning was strong enough to warn people about the potential risk, Pfizer must file a summary judgment motion in each case.

Attorneys for plaintiffs and defendants are currently preparing their cases for trial. The first trial in the Chantix MDL is schedule to begin on October 22, 2012.