One of the first lawsuits over Pfizer’s smoking cessation drug, Chantix, is becoming official this week. The lawsuit alleges that the use of Chantix led David Collins of Gas City, Indiana, to commit suicide in January and that Pfizer failed to issue proper warnings about psychiatric side effects. Collins’ widow, Linda, filed the suit Tuesday in a U.S. District Court in Indianapolis. According to the lawsuit, Collins began using Chantix in October 2007. Linda’s lawyer claims David had no history of psychiatric problems.
The lawsuit alleges that Pfizer purposely excluded people with a history of mental illness when it tested Chantix during clinical trials. ”I run a clinic, and two out of three (smokers) I see have psychiatric or mood problems,” Dr. Daniel Seidman, director of Smoking Cessation Services at Columbia University Medical Center, is quoted in the suit. The suit also alleges the active ingredient in Chantix was derived from cytosine. Cytosine has been linked to suicide and the suit alleges Pfizer should have known about that link based on documentation dating back over 30 years. The suit also alleges Pfizer historically delays publication of scientific papers if such papers contain results unfavorable to the marketing of its products. The Institute for Safe Medication Practices recently reported that it has received notice of nearly 1,000 serious side effects related to Chantix.
Meanwhile, the US Food and Drug Administration (FDA) recently approved the Medication Guide on Chantix and issued an alert to highlight changes to the “Warnings and Precautions” section of the full prescribing information regarding serious neuropsychiatric symptoms linked to Chantix. Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and both attempted and completed suicide. Many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning—the agency’s highest safety alert.
Despite this, health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking despite the drug’s association to suicidal thoughts and behavior. And, while the new smoking cessation guidelines, published by the US Public Health Service, do note the Chantix links with suicide and other psychiatric side effects, the Pfizer drug is promoted as the method most likely to help smokers wanting to quit. The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also because their lead author, Dr. Michael Fiore, has ties to Pfizer.
As FDA’s review of the problems with Chantix has continued, the FDA states it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” It was because of this that the FDA requested that Pfizer elevate the prominence of this safety information. In the US, 34 Chantix users have reportedly committed suicide. According to an FDA November 20 Early Communication, the agency said its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.