non smoking

Pfizer Settles on Chantix Anti-Smoking Drug Case

non smokingPfizer Inc. is facing thousands of lawsuits regarding its popular anti-smoking drug Chantix. One of these lawsuits, alleging that the company did not properly warn doctors or patients of the increased suicide risk for those who take the drug, reached a settlement. The settlement, which came less than a week before the trial was to begin, remains confidential.

The trial judge, U.S. District Judge Inge Johnson had order top Pfizer executives to appear as witnesses at the trial. It is thought that this contributed to Pfizer’s decision to settle.

The case was brought by the family of a Minnesota man named Mark Alan Whitely who died in November 2007. The plaintiff’s family states in the suit that Pfizer was at fault in that it failed to adequately warn that taking the drug may increase a patient’s risk for suicide.

Chantix already contains the Federal Drug Administration’s (FDA) (www.fda.gov) highest warning, a black-box warning, which lists potential side effects as changes in behavior, agitation, hostility or depression. While risk of suicide is mentioned on the label, plaintiffs claim that this is not sufficient protection for such a severe potential safety risk.

Pfizer states that Chantix did not cause suicide in patients and that the existing warning was sufficient. Since 2006, the labeling of Chantix has been upgraded several times to increase the strength of the warning messages. The FDA ordered the current black-box warning in July 2009. Critics argue that the severe warning level should have come much sooner to avoid potential harm to patients.

Chantix is a medication which helps people to quit smoking. It works by binding to the same receptors in the brain as nicotine. At the same time it releases dopamine which causes the feel-good sensation experienced by smokers.

Chantix Feared By Some Groups

The Federal Aviation Administration has banned the use of Chantix for air traffic controllers and pilots due to the potential side effects of agitation and hostility.

The FDA will continue it studies of the effects of Chantix, however the agency recommends that patients using Chantix review their treatment with their doctor. Patients should be aware of any side effects they may be experiencing. In addition, Pfizer is conducting a long-term study of patients and the behavioral effects of Chantix. Study results are not expected until 2017.

More than 2500 Chantix lawsuits are pending in the Federal Court system in Alabama. The next round of litigation against Pfizer and Chantix will be in Alabama Federal Court in January 2013.

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