Do you need a Chantix Lawyer? – Free Call, No Obligation

If you or someone you love has taken Chantix, you should be aware of new warnings on the drug’s label concerning serious health risks.

Contact our personal injury law firm today. A consultation with a product liability lawyer may be in your best interest. If Pfizer knew the risks of taking Chantix were more dangerous than it claimed, you may be entitled to compensation for the injuries you may have suffered as a result.

Our product liability lawyers are investigating the circumstances surrounding this drug. Your information will be reviewed by a lawyer who may be able to help you gain compensation from a Chantix lawsuit.

Chantix may be harmful for patients. - Smoking cessation drug linked to suicidality

Chantix, known generically as varenicline, is a non-nicotine prescription smoking cessation drug in pill form manufactured by Pfizer, Inc. The drug works by inhibiting pleasure receptors in the brain that provide a psychological “reward” when they interact with nicotine.

In November 2007, the United States Food and Drug Administration (FDA) released information for Chantix patients regarding reports of suicidal thoughts and aggressive and erratic behavior in patients, with one patient death. At the time, the FDA was unable to establish a direct link between Chantix and the reported severe mood and behavioral changes.

By the end of November 2007, the FDA reported receipt of 5,157 adverse event reports involving Chantix, including 417 reports of depression, 199 reports of suicidal thoughts, and 55 suicides. Hundreds of other Chantix patients reported additional neuropsychiatric events, including aggression, hallucinations, and amnesia. It was revealed that European patients taking the drug, sold overseas as Champix, have also raised complaints of suicidality and neuropsychiatric events since the drug’s release in 2006.

By January 2008, Pfizer updated its Chantix label to include numerous reports of suicidality, erratic behavior, and depression. While Pfizer insisted there was no causal link between these behavior changes and Chantix, it said the seriousness of the side effects prompted the updated label.

In February 2008, the FDA issued a public health advisory concerning these side effects after receiving additional reports of adverse events from patients worldwide. The advisory urged patients to be aware of severe mood and behavioral changes, and encouraged close monitoring of Chantix patients by loved ones.

Three months later, in May 2008, the FDA issued another public health advisory concerning Chantix. At the request of the FDA, Pfizer added specific warnings about the possibility of severe changes in mood and behavior in Chantix patients, including suicidality and depression.

Smokers with psychiatric illnesses excluded from Chantix clinical trial

It is estimated that 44 percent of all cigarettes in the United States are smoked by people with diagnosed mental disorders, including schizophrenics and alcoholics. Smokers with psychiatric illnesses were not included in Phizer’s premarketing trials for Chantix, however, leading to one possible explanation for the flood of adverse event reports. Chantix is marketed and sold to all adult smokers, regardless of mental health status.

In addition, Pfizer knew or should have known Chantix could be associated with an increased risk of suicidality and neuropsychiatric events because the active ingredient in Chantix, varenicline tartrate, is derived from cytosine. Cytosine has been used for decades as a smoking cessation drug in Eastern Europe, but as early as 1972 reports linked the drug to cases of suicide and attempted suicide.

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Sources:

“Early Communication About an Ongoing Safety Review, United States Food and Drug Administration, November 20, 2007; “Chantix Patient Information Sheet, United States Food and Drug Administration, November 20, 2007; Janet St. James, “FDA releases over 5,000 Chantix complaints,” WFAA.com, November 29, 2007; Catherine Paddock, “Europe Wants Warnings On Champix Smoking Cessation Drug,” Medical News Today, December 17, 2007; Philip Dawdy, “Pfizer adds warning to Chantix,”; Furious Seasons, January 18, 2008 Avery Johnson, “Pfizer beefs up warnings on Chantix,” Wall Street Journal, January 18, 2008; “FDA issues public health advisory on Chantix,” Food and Drug Administration Press Release, February 1, 2008; Matthew Perrone, “FDA: Chantix may pose psychiatric risks,” Kansas City Star, February 1, 2008; “Public Health Advisory: Important Information on Chantix (varenicline),” United States Food and Drug Administration Public Health Advisory, May 16, 2008; Melinda Beck, “Puff Power: Drug Warnings Speak to Nicotine’s Sad Grip,” Wall Street Journal, February 19, 2008; Kristian Ramussen and Elizabeth Chambers, “The Next Mass Tort: Chantix,” American Association for Justice Section on Toxic, Environmental and Pharmaceutical Torts (STEP) Newsletter, Spring 2008.