TV Ads for Smoking Drug Chantix Resume Despite Suicide Side Effects
Chantix (varenicline tartrate) was once considered the most promising drug in Pfizer’s pipeline of new medications, which has been proven effective at helping people quit smoking. After the drug was approved by the FDA in 2006, it quickly became a top selling drug, with annual sales of $883 million in the first full year it was on the market
As a number of reports surfaced of users committing suicide, attempting suicide or experience sudden aggressive behavior, concerns emerged about Chantix side effects and whether the benefits outweigh the potential risks.
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In November 2007, the FDA initiated a review of emerging safety questions about Chantix after identifying at least 39 Chantix suicide deaths and nearly 500 reports of suicidal thoughts. At that time, Pfizer was not providing any warnings on the label or in advertisements about the potential Chantix suicide side effects.
Earlier this year, Pfizer did add information to the warning label about the potential psychiatric side effects of Chantix. Around January 2008, they also decided to halt all television advertisements for Chantix.
FDA regulations require pharmaceutical companies to disclose possible side effects concerning their medications in all advertisements and promotional materials. This is required so that doctors and consumers are able to fully evaluate the risks and benefits of any treatment.
Last month, Pfizer generated some controversy by running television advertisements during the Olympics which did not mention the potential suicide side effects of Chantix. The ads were designed to increase sales of the stop smoking drug by directing viewers to a Pfizer website, MyTimeToQuit.com. However, because the drug was not specifically named during the 60 second commercials, Pfizer was not required to disclose the potential risks by the FDA and they chose not to provide that information to consumers.
According to an article in Forbes, Pfizer will return to a branded campaign in the new Chantix advertisements, which are 90 second ads. Approximately 40 seconds of the advertisement will be used to educate potential consumers about the potential Chantix side effects, and to warn against using the drug if they experience suicidal thoughts, behavior or agitation.
A number of Chantix lawsuits have already been filed on behalf of people who took their own life or suffered severe injuries from a suicide attempt or unusual aggressive behavior while taking the drug. The lawsuits claim that Pfizer failed to adequately warn about the potential side effects which allegedly resulted in these injuries.
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