Friday, February 25, 2011

Chantix Suicide Risk Requires Stronger Warning

Two known and potentially deadly side effects of Chantix—Chantix depression and Chantix suicide—are many times not listed among the possible Chantix side effects named in the product’s pamphlet. These particular side effects are specified separately as possible “severe” side effects that mandate professional medical assistance if they are experienced. Yet many feel that this amended warning is still not strong enough to effectively alert users to the dangers these side effects represent. Even among users with no prior history of mental disorder or depression, severe Chantix depression and suicide can develop very quickly.

Chantix Suicide Identified Shortly After Debut

Pfizer, Inc. is the manufacturer of Chantix, a drug commonly prescribed to cigarette smokers to help them in their efforts to quit. The medicine was approved by the Food and Drug Administration in 2006, but soon after there were reports of extremely adverse effects and events that resulted in the discovery of Chantix’s potential psychological side effects. These include serious conditions such as depression, thoughts of suicide, severe mood swings, and acts of aggression.
Yet Pfizer continues to insist that the drug is a boon to society in that it serves as an effective treatment for patients who need help quitting smoking. Chantix functions by blocking the brain’s receptors that are normally stimulated by nicotine consumption. This results in less pleasure derived from the act of smoking.

Chantix Lawsuits Claim Negligence by Drugmaker

The first report of a Chantix suicide came after the widow of a former Chantix user filed a wrongful death lawsuit against Pfizer in July 2008. Her husband, a man with no prior history of any mental illness, committed suicide after taking Chantix for a few short months. Many more Chantix suicide lawsuits were filed soon thereafter, resulting in multidistrict litigation for all such suits filed in a federal court.
These lawsuits make claims that Pfizer seriously misrepresented the true risks linked with Chantix use, and that this misrepresentation constitutes a reckless and criminally negligent act on the manufacturer’s part. The lawsuits further allege that Pfizer put consumer’s lives at risk by failing to conduct sufficient research on the drug, and by omitting adequate warning statements that both doctors and patients are entitled to.

Chantix Drug Trials and Inserts Flawed from Start

When drug trials were first conducted for Chantix, they excluded all individuals who had a past history of psychiatric troubles or a current psychiatric disorder. Therefore people with relatively commonplace problems such as depression, bipolar disorder, and schizophrenia did not factor into the results of the trial. It has been estimated that around two out of every three smokers do in fact have past experience with or are currently suffering from some kind of psychological disorder related to mood, whether the symptoms be mild or severe. Since people with these types of disorders were not included in the trials, yet the intended consumers of the drug are likely to be made up of people with these same disorders, negligence on the part of the manufacturer is apparent.
Originally, the Chantix warning information mentioned several possible side effects ranging from suicidal thoughts to nausea. But the waning label has been altered several times since the drug was originally given the green light by the FDA in 2006. In the end the FDA made it mandatory for Pfizer to change the Chantix black box warning so that it included information specific to the drug’s possibly life threatening side effects. This is the strongest cautionary measure that can be applied to the warning label of any prescription drug.

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