All of the nearly 2,900 lawsuits against the smoking cessation drug Chantix have been settled for approximately $300 million, and a federal judge in Alabama ruled earlier this month that the nationwide litigation should be dismissed.
More than 10 million smokers in the U.S. have been prescribed Chantix to help them stop smoking. The drug is highly effective as an aid to smoking cessation, but it has been blamed for triggering suicidal thoughts, behavioral changes, hostility, agitation, depression, and other psychological problems in patients.
In September, the U.S. Food and Drug Administration updated the warnings and precautions section on Chantix to include information from some new studies that have found that the drug’s psychological effects may not be as bad as originally thought, but an FDA advisory panel voted overwhelmingly on October 16 to retain the most serious warnings. Pfizer Inc., the manufacturer of Chantix, had been seeking to have the Black Box warning removed, but only one advisory panel member voted in favor of removal, while 11 voted to maintain the warning, and six voted to strengthen the labeling to include references to sleep disturbances.
The panel also recommended that any further changes to the Black Box warnings should not be considered until after Pfizer completes a post-marketing study anticipated in the third quarter of 2015. Had the Black Box warning been removed, it would have been difficult to have it reinstated later, even if the post-marketing study showed negative findings, what some experts consider to be a motivating factor in the company’s urging to have the warnings removed.
Soon after Chantix was approved for use in 2006, the drug has been associated with reports of suicide and violence. Sales fell to $648 million in 2013 from $846 million in 2008, and Pfizer has spent hundreds of millions of dollars to settle the lawsuits.