|Pfizer's smoking cessation drug Chantix.--Courtesy of Kaiser Permanente|
About 80% of Pfizer's Chantix litigation is finito. The drugmaker has settled or agreed to settle about four-fifths of 2,700 state and federal lawsuits, and took a $273 million charge to cover the costs, a securities filing notes. Pfizer ($PFE) has set aside another $15 million toward wrapping up the rest of the claims.
The batch of settlements follows two deals in individual cases chosen for "bellwether" trials in U.S. Judge Inge P. Johnson's Alabama court. Last October, the company came to an agreement with the wife of Mark Whitely, a Chantix user who committed suicide. In January, it settled with plaintiff Billy G. Bedsole, Jr., who claimed that Chantix triggered suicidal thoughts and other psychiatric problems. The terms of both settlements weren't disclosed.
Chantix drew fire after reports of suicide, suicide attempts and other psychiatric disturbances. FDA required a "black box" warning on the drug, to alert patients and doctors to the risk of psychiatric side effects. Critics said Pfizer's Chantix trials had improperly excluded patients with a history of depression or other mental disturbances.
In answer, the company sponsored a trial of Chantix in patients who were either depressed or had a history of depression. It beat placebo at helping patients quit smoking, the study found. The trial also assessed participants' psychiatric health and found no differences between the two arms, Pfizer said at the time. Pfizer tried--and failed--to persuade Johnson to postpone one trial to allow for admission of the study data.
Now, the FDA has determined that Chantix is probably associated with a higher heart attack risk. But the agency also emphasizes that smoking comes with enormous risks to the heart, and quitting can change that. Pfizer has disputed the research that informed the FDA's opinion on the subject, and continues to stand by the drug's risk-benefit balance.
"Chantix is an important, FDA-approved medication and effective treatment option for adult smokers who want to quit," Pfizer said in a statement on the settlements (as quoted by Alabama Live). "Smoking is the number one cause of preventable death in the United States, and the health benefits of quitting smoking are immediate and substantial. We are confident in the benefit-risk profile of this medication and are committed to defending it."