Wednesday, April 20, 2011

Chantix Lawsuit Over Safety Concerns

Chantix lawsuits have been consolidated in the Northern District of Alabama after side effects became apparent in numerous patients who had taken the popular smoking cessation aid. Many plaintiffs are taking issue with the fact that initial clinical trials seemed to prove that the drug was safe and posed limited risk of side effects – however, the clinical trials failed to include individuals with a history of mental health issues or psychiatric problems, many of whom are smokers and would therefore be likely to use Chantix.

Chantix, which was once hailed by the Public Health Service as the most effective smoking cessation aid on the market, was first sold in 2006. Clinical trials showed promising results with few side effects, and it was granted a priority review by the Food and Drug Administration due to its apparent safety and effectiveness. It works by reducing cravings for nicotine while also minimizing side effects of nicotine withdrawal, and binds with nicotine receptors in the brain to accomplish this.

Chantix side effects began to surface in some patients very soon after they began treatment. These side effects have been known to include mood swings, aggressive behavior, depression, suicide ideation or suicide attempts, and other psychological disturbances. Based on reports sent to the Food and Drug Administration by the Institute of Safe Medicine, between May 2006 and December 2007 there were 525 reports of Chantix-related aggression, 397 cases of psychosis, and 227 cases of suicidal acts or thoughts.
The Food and Drug Administration issued a black box warning for Chantix, which educated consumers of the potential for these psychiatric side effects. However, this warning came too late for many patients, and subsequently Chantix lawsuits were filed against drugmaker Pfizer. Many of these lawsuits were consolidated in a multidistrict litigation case, which will help plaintiffs out by speeding up the pretrial process.

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