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Study Suggests Updated Chantix Warnings

According to a recent study published in the online journal PLoS One, serious acts of violence towards others may be directly correlated to the use of the popular smoking cessation drug known as Chantix (varenicline). Those involved with the study are pleading for the U.S. Food and Drug Administration (FDA) to strengthen the warning label on Chantix products. Subsequently, efforts to increase Chantix warning labels have been strengthened by proponents of the idea, citing data that suggests the drug significantly increases the risk of developing suicidal behavior or depression.

Chantix was originally introduced to interstate commerce by Pfizer in 2006. Soon after gaining the FDA’s approval, Chantix became one of the most popular smoking cessation medications on the market. However recent studies have suggested that Chantix side effects may include neuropsychiatric injuries leading to behavioral changes, depression, aggression, agitation, hostility, rage, suicidal ideation, suicide attempts and, in many cases, successful suicide.

In response to the influx of adverse neuropsychiatric complications, the FDA placed a “black box” warning on Chantix in 2009 that indicated the increased risk of depression, hostility and suicidal thoughts. However, recent studies suggest that the warnings for the smoking cessation drug need to be increased. Dr. Curt Furberg, a professor of public health sciences at Wake Forest Baptist Medical Center and one of the authors of the recent PLoS One study, acknowledged that Chantix placed patients at a higher risk of developing psychological symptoms.

Furberg and his colleagues analyzed more than 3,000 reports of suicidal behavior and depression contained in the FDA’s Adverse Event Reporting System. According to those reports, approximately 90 percent of the adverse incidents were associated with the use of Chantix. Subsequently, 92 percent of the successful suicides reported were also Chantix related.

These findings lend incredible weight to the long-suspected link between Chantix and neuropsychiatric injuries. Furberg acknowledged the evidence, saying “the dramatic increase of these symptoms are caused by the drug. Among all the treatments we have for smoking cessation, Chantix is the worst.” Thus, Furberg proclaims that the benefits of stopping smoking don’t outweigh the risks of the psychological symptoms connected to Chantix.

“Smoking is bad and if we have an effective treatment for smoking cessation, I would promote it,” Furberg said. “But the benefit of this drug is so weak that you can’t tolerate the bad effects that come with it.”

However, contradictory to Furberg’s findings, are the beliefs of the FDA. A spokeswoman for the agency said the drug is a safe and effective method to quit smoking. Additionally, the agency claimed that Furberg’s study did not account for the influx of adverse events that were reported because of media influence since 2007.

As predicted, Pfizer refuted Furberg’s remarks, saying that the study produced unreliable results. “Post-marketing reports can come from any source ranging from patients to healthcare providers, and from phone calls to internet postings and lawyers. Often these reports lack sufficient medical information to enable meaningful assessment,” Pfizer representatives said in a statement.

The influx of adverse psychological injuries associated with Chantix have not gone unnoticed. The FDA is still determining the safety and effectiveness of the smoking cessation medication. At the FDA’s request, Pfizer is currently conducting a clinical trial to study the link between Chantix and psychological side effects. The results are expected in 2017.

Do I Have a Chantix Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Chantix lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by Chantix, you should contact our Chantix lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.

Categories: Product Liability
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