Serious Risks Associated with Pfizer's Chantix

If You're Taking Chantix You Need to Understand the Risks

If your doctor has prescribed Chantix to help you stop smoking, you should be aware of the serious dangers associated with taking Chantix and carefully consider whether you are a good candidate for this drug.

Chantix is the brand name for the pharmaceutical drug varenicline that is intended to help patients quit smoking. Pfizer requested and received an accelerated review by the FDA and Chantix was approved for use in the United States in May of 2006. As Pfizer predicted Chantix quickly became a top selling drug for the company with annual sales of $883 million in the first full year it was on the market.

In simplified terms, Chantix dulls the sensors in the brain associated with pleasure, so while Chantix is somewhat effective in reducing the positive feelings in the brain by blocking the brain receptors commonly stimulated by nicotine, the impact of the drug on the brain has resulted in numerous reports of sudden, unusually aggressive behavior, thoughts of self-harm and suicide.

The Dangerous Side Effects of Chantix

The side effects of Chantix are numerous and varied, some of them very dangerous. Many critics claim Pfizer failed to properly test the drug, and did very little to warn consumers of the host of risks when the drug entered the stream of commerce. More dangerous side effects have been reported each year the drug has been available for use. Chantix is associated with and is believed to cause neuropsychiatric injuries characterized by dramatic behavioral changes. The most dangerous side effects linked to Chantix are suicide, suicide ideation and psychotic behavior. An alarming number of Chantix users have taken their own lives or seriously injured themselves in an attempt at suicide. Others have suffered depression, anxiety, nervousness, agitation rage and hostility. Chantix is also believed to cause serious heart rhythm disturbances, such as acute myocardial infarction, seizures, and muscle disorders. Physical impairment, dizziness, loss of consciousness, unusual behavior, mood swings, muscle spasms and skin problems have also been reported.

The Institute for Safe Medication Practices has said that even more problems are being identified. In addition to the reported heart and cardiovascular problems that have been previous identified the Institute believes that there may be an association between Chantix and serious injury accidents from falls which many suspect is caused by the visual disturbances reported with Chantix. The Institute also found continued reports of aggression and suicide. Chantix has also been linked to Stevens Johnson Syndrome, a potentially deadly skin disease.

Inadequate Drug Testing

Ironically, Chantix began as a success story; early promotional claims boasted that a significant 44% of people taking Chantix were able to quit smoking in comparison to 17.7% percent of those taking placebos. By blocking nicotine from stimulating certain brain receptors, smokers don't get the dopamine boost they would normally receive when they smoke. But as the number of reports surfaced of users committing suicide, attempting suicide or experience sudden aggressive behavior, concerns emerged about Chantix side effects and whether the benefits outweigh the potential risks.

In November 2007, the FDA initiated a review of emerging safety questions about Chantix after identifying at least 39 Chantix suicide deaths and nearly 500 reports of suicidal thoughts. At that time, Pfizer was not providing any warnings on the label or in advertisements about the potential Chantix suicide side effects. Not long afterwards the U.S. government (FAA) banned pilots and air traffic controllers from using Chantix because of its reported dangerous side effects.

Pfizer pulled all advertisements for Chantix in 2008 due to mounting concerns of increased suicide risks. In June 2009, a "black box" warning, the highest level of warning from the FDA, was added to the medication about the potential risk of problems with Chantix, indicating that some users have experienced changes in behavior, depression and suicidal thoughts. Remarkably, Pfizer has since re-launched a national TV campaign for their stop smoking drug despite the serious dangers associated with taking Chantix.

Chantix Litigation

A number of Chantix lawsuits have already been filed on behalf of people who took their own life or suffered severe injuries from a suicide attempt or unusual aggressive behavior while taking the drug. The lawsuits claim that Pfizer failed to adequately warn about the potential side effects which allegedly resulted in these injuries.

Lawsuits against Pfizer for injuries suffered from using Chantix allege that Pfizer failed to effectively study Chantix to determine the risk of serious injury or death associated with its use, that Pfizer intentionally excluded certain patients and populations from clinical trials and that Pfizer intentionally ignored the proper evaluation process. Perhaps blinded by the potential profit power of a successful stop smoking drug, critics claim Pfizer simply failed to address frequent reports of depression, aggression, suicide, suicidal ideation, suicidal thoughts, suicidal tendencies, and other injuries mentioned above.

Patients now claim that Pfizer is responsible for failing to determine what other effects Chantix has on other receptors in the human brain and body, and that they intentionally failed to include appropriate measures of adverse events in clinical trials.

For example, while studies suggest that nearly half of all cigarettes aresmoked by people with mental illness, Pfizer admitted that "[p]atients with serious psychiatric illness such as schizophrenia, bipolar disorder, and majordepressive disorder did not participate in the controlled clinical trial program."

Dr. Daniel Seidman, the director of Smoking Cessation Services at Columbia University Medical Center, is reported to have said in a recent article,

"When [Pfizer] tested the drug, the sample they chose simply isn't representative of the people they're targeting. . . . By excluding drinkers, you're artificially inflating your results, potentially. I run a clinic, and two out of three [smokers] I see have a psychiatric or mood problem. None of these people would have been part of the original trials."

Angel Law, P.C. litigates dangerous drug cases and a Chantix litigation lawyer at Angel Law, P.C. is now investigating cases involving not only suicides but also cases involving, lethal cardiac rhythm disturbances, acute myocardial infarction, seizures, and psychosis. If you or a loved one has used Chantix and has experienced an injury as a result of any of these symptoms or events, call a Chantix class action lawyer at Angel Law, P.C.

Click here to review the warning on Varenicline (Chantix) published by the US National Institute of Health.