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Monday, March 23, 2015

Chantix: Helping or Harming?

Chantix: Helping or Harming?
By Anna Blood, Intern
The Cochran Firm

In May of 2006, the FDA approved the use of Chantix, also known as Varnecline, in the United States. Chantix’s approval was based on controlled trials conducted over a 6 to 12 weeks period on over 3,500 chronic cigarette smokers (average of 21 cigarettes per day and average smoking history of 25 years). Chantix offers the benefit of relieving symptoms of nicotine withdrawal and cigarette craving by blocking the effects of nicotine.

Chantix’s original FDA approved labeling included a list of the following neuropsychiatric side effects: insomnia, abnormal dreams, and nightmares. However, as information about these side effects began to develop, the labeling was changed.

In January 2008, based on several reports of serious neuropsychiatric side effects, the FDA determined that Chantix was associated with suicidal behavior, changes in behavior, agitation, depressed mood, and worsening of preexisting psychiatric illness. A new warning was added describing these side effects, as well as adding new recommendations for patients, their families and caregivers to monitor for these side effects during the drugs use.

Further, in May 2008, the FDA, acting under the FDA Amendments Act of 2007, required Pfizer to implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of Chantix as an aid to smoking cessation outweighed its risks. The REMS required a Medication Guide to ensure that Chantix patients were aware of the risk of neuropsychiatric side effects. Additionally, the FDA required Pfizer to conduct a controlled trial to assess these risks.
Finally, in July 2009, a boxed warning was added to include other neuropsychiatric side effects which included hostility, agitation, mania, psychosis, hallucinations, depressed mood and suicidal thoughts or actions. Recommendations were given to patients and their caregivers to discontinue Chantix if these side effects occurred.
Just this month, the FDA released a Drug Safety Communication updating Chantix ‘s warning label to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior and thinking. The FDA based its findings on studies from Pfizer, as well as a review of cases in the FDA Adverse Event Reporting System database (FAERS) which showed that some patients experienced decreased tolerance of alcohol, increased drunkenness, unusual or aggressive behavior, or they had no memory of events that had occurred. 
These reports also contained cases where patients had seizures while taking Chantix and either had no history of seizures or had a seizure disorder that had been well controlled. Most of these seizures occurred within the first month of using Chantix. The FDA is recommending that Healthcare professionals weigh the risks of seizures against the potential benefits before prescribing Chantix in patients with a history of seizures.
 The FDA states that until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.
As a result of the serious side effects associated with Chantix, there have been numerous lawsuits against Pfizer over the past decade. The first lawsuit filed against Pfizer regarding Chantix was in Indiana in 2008 by the law firm of Cory, Watson, Crowder & DeGaris.
By 2010, there were at least 1,200 Chantix lawsuits, with most plaintiffs seeking damages associated with suicide and depression. That year, the U.S. Judicial Panel of Multidistrict Litigation transferred all Chantix side effects lawsuits to the District Court in Alabama and appointed U.S. Judge Inge Johnson of the Northern District of Alabama to handle all pretrial proceedings and civil trials not settled out of court.

In October 2012, Johnson heard two lawsuits against Pfizer as a part of a pool of eight selected to be test cases in the litigation. The first of these claims was brought by the widow of Mark Whitely, a man who committed suicide after taking Chantix. The second claim was brought by Billy G. Bedsole Jr. who stated that the drug caused him to have suicidal thoughts and other psychiatric problems. Both cases were settled for undisclosed amounts.
By 2014, nearly 2,900 lawsuits claiming Chantix triggered suicidal thoughts and other psychological problems had been settled for about $300 million in Federal Bellwether trials in Alabama. Courts utilize a bellwether approach when large numbers of plaintiffs are proceeding on the same theory or claim and there is no other feasible way for the courts to handle the enormous caseload.

Despite the seemingly end in litigation with Pfizer concerning neuropsychiatric side effects such as suicide, the recent FDA warnings about seizures are a sign that the fight is not over and that litigation over this new issue is just beginning. Pfizer will likely continue to advocate for the use of its products while consumers now face the threat of seizures in their use of the smoking cessation drug, Chantix.

posted by The Cochran Firm at 12:49 PM

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