Lawsuit: Pfizer Knew Psychiatric Risks of Anti-Smoking Drug Chantix Before Launch

Pfizer (PFE) knew as early as 2005 that its stop-smoking drug Chantix carried a threefold risk of psychiatric disorders but failed to disclose that in a study published in 2007, according to a lawsuit filed by the estate of a couple who died in a murder-suicide on the front lawn of their Economy, Pa., home.

The case is one of at least 275 filed alleging the company failed to disclose that Chantix (sold as Champix in foreign territories) carries increased risks of depression, aggression, hostility, rage, suicidal ideation and actual suicide.

It also makes the unusual claim that Pfizer's unbranded educational campaign to encourage people to give up cigarettes in 2007 and 2008 was "sneaky" because it failed to warn of Chantix's risks. Unbranded campaigns do not specifically advertise quit-smoking drugs, and are therefore not required to carry safety warnings. In response to the suit, Pfizer said:

We are reviewing the circumstances of this case, but no causal relationship has been found between the medicine and neuropsychiatric events such as those alleged here.

What Pfizer knew
Chantix was launched in 2006, but warnings of psychiatric disorders were not included on Chantix's prescribing information label until November 2007.

The suit claims that Pfizer played down the psychiatric aspects of Chantix by weeding out anyone with a history of mental illness from its studies of the drug. Up to half of all cigarettes are consumed by
people with a mental illness, the suit alleges. In 2003-2005 study conducted by Pfizer, patients on Chantix had three-fold risk of psychiatric disorders, the suit claims, but Pfizer did not disclose that when the study was published in 2007:

Two other patients in Pfizer's early studies attempted suicide despite having no previous psychiatric disorders, the suit says.

In fall 2007 and early 2008, three Pfizer executives denied in press reports that there were increased risks of violence and self-harm, by suggesting that smokers who were also drinkers had increased risks of psychiatric disorders, or by alleging that giving up smoking itself increases aberrant behavior, the suit says.

More recent studies have alleged that violence is 18 times more likely to occur among Chantix users than non-Chantix users.

No brand, no warnings
When Pfizer launched Chantix in 2007 it used an unbranded "help-seeking" campaign that did not mention Chantix by name. At the time, drug companies were under pressure to be more responsible with their drug advertising, and Pfizer had pledged not to run ads for any new drug brand in the first six months after its launch. Instead, the company ran a general anti-smoking campaign titled "My Time to Quit," which included a web site and a phone number for people seeking help or information. The campaign materials eventually led people to the Chantix web site.

The campaign carried two benefits for Pfizer: It helped demonstrate that the company was sticking to its promise of making its advertising more educational. But as Chantix was the only prescription stop-smoking pill, any general campaign for Rx solutions to smoking benefited only Chantix, as Chantix was the only Rx pill in that category at the time. Thus, the suit argues, Pfizer got to advertise its new drug without cluttering up its campaign with all the required "fair balance" information about risks and side effects that bedevils most pharmaceutical advertising.

Complaints about Chantix have since fallen off dramatically, according to the DrugCite database, even though sales of the drug were up to $755 million in 2010:

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• Anti-Smoking Drug Linked to Violence, but Pfizer's Data Says the Opposite