PITTSBURGH (CN) – Pfizer has faced hundreds of complaints that its anti-smoking drug Chantix caused suicidal ideation and suicide attempts. Now a federal lawsuit claims the drug is responsible for a murder-suicide that left four children orphans.
Chantix, generically known as Varenicline, was launched in the U.S. market in May 2006, after the FDA rebuffed Pfizer’s request to call the drug “Champix,” a name the FDA called “overly fanciful,” according to the complaint from the administrators of the Estates and Natalie and Sean Wain.
The plaintiffs-administrators are the fathers of the late husband and wife. They say the injuries to their children and grandchildren “directly resulted from using Chantix.”
The estates claim that Pfizer spent more than $100 million promoting Chantix from 2007-2008 alone.
But they say the materials the world’s biggest drug company provided to doctors were woefully inadequate and “downplay or omit information about the serious adverse effects of Chantix.”
Those adverse effects are serious indeed, as they include “the potential of violent behavior, rage, serious injury and death,” according to the complaint.
The side effects culminated when 34-year-old “Sean M. Wain consumed Chantix which caused decedent rage and which, in turn, resulted in violent behavior and the deaths of Sean M. Wain and Natalie N. Wain on or about May 17, 2009,” the complaint states.
The Wains left four minor children.
The 60-page complaint does not use the phrase “murder-suicide.” That apparent turn of events is deduced from the complaint and from contemporary media reports.
The children’s grandfathers accuse Pfizer of a slew of improprieties in developing and marketing the drug, including “intentionally excluding certain patients and populations from clinical trials. … For example, while studies suggest that nearly half of all cigarettes are smoked by people with mental illness, defendant admitted that ‘[p]atients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the controlled clinical trial program. …’
“Because of defendant’s systematic exclusion of patients with a history of psychiatric disorders, the safety of Chantix in smokers with psychiatric illness was never established. But defendant did not mention this in its labeling until January 2008,” according to the complaint.
Pfizer’s own 52-week study revealed that “the relative risk that Chantix patients would suffer psychiatric disorders was more than three-fold that of patients on placebo,” but Pfizer did not disclose that when it published the study, the complaint states.
One study participant who was given the drug had to be hospitalized for 11 days after experiencing suicidal ideation, the grandfathers say. They add that a participant in a study conducted by the Journal of the American Medical Association actually committed suicide.
The AMA reported cases of “acute psychosis, emotional liability, insomnia, and abnormal dreams” in Chantix users, and the FDA received similar feedback, according to the complaint.
“In the 4th Quarter of 2007, Varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other drug in this time period. By comparison, the FDA received a median of 5 reports of serious injury for 769 different drugs in the 4th Quarter,” the complaint states.
“Many of the cases received and reviewed by the FDA were reported for patients without any prior history of psychiatric illness,” it adds.
By July 1, 2009, the FDA had received 98 reports of Chantix-related suicide, the complaint states.
But “despite its early internal knowledge that Chantix causes neuropsychological side effects, defendant has diluted its label and prescribing information by minimizing and questioning the validity of post-marketing reports and epidemiological studies that reported an association between Chantix and neuropsychiatric and other side effects,” according to the complaint, which cites statements from high-ranking Pfizer officers, including a former vice president and medical director, who repeatedly told the public that no such association existed. (See page 16 of the attached complaint.)
After the Institute for Safe Medication Practices released a scathing report that raised “immediate safety concerns” about Chantix, Pfizer responded by “embarking on a massive and deceptive publicity campaign to downplay the connection between Chantix and neuropsychiatric and other adverse events,” the complaint states.
“Pfizer representatives attempted to divert attention from safety issues contained in the report by discussing the benefits of quitting smoking, questioning the reliability of the report’s methods, suggesting that the reported neuropsychiatric problems were caused by nicotine withdrawal or even smoking itself, and again misrepresenting its internal knowledge by insisting that the reported behavioral changes were not caused by Chantix and that Chantix was safe,” the complaint states.
Pfizer failed to explicitly warn on packaging that Chantix caused an increased risk of serious injury and death, and subsequent changes to the packaging were dilatory and still insufficient, the estates say.
And while the data remain inconclusive, when it comes to quitting smoking, the estates say studies indicate that “Chantix appears to be no better than placebo or the nicotine patch.”
The estates say they deserve equitable tolling in the case, and demand punitive damages.
Their attorney, Victor Pribanic with Pribanic & Pribanic in White Oak, Pa., did not respond to a call requesting comment.
Pfizer spokesman MacKay Jimeson told Courthouse News in a statement that the company is “reviewing the circumstances of this case, but no causal relationship has been found between the medicine and neuropsychiatric events such as those alleged here.”
A federal judge in Birmingham, Ala., is overseeing more than 1,200 Chantix-related lawsuits from multiple districts, involving similar allegations of psychological side effects and suicides.