Reports of Chantix suicide prompted the FDA to require a black box warning about Chantix side effects to be placed on the smoking cessation drug. Besides the association between Chantix and suicide, the FDA also received a number of Chantix aggression reports.
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Chantix
The first Chantix warnings were announced by the FDA in late 2007 and three months later, the agency said it that there may be an association between Chantix and serious neuropsychiatric symptoms. In June 2007, Pfizer, the manufacturer of Chantix, was required to add a boxed warning about Chantix side effects and the risk of behavior changes, including depression, aggression and attempted suicide.
The FDA has reported 491 cases of suicidal thinking or behavior, including 420 in the US. And of those, there were 39 suicides, including 34 in the US.
Chantix (varenicline) was approved in 2006 to help people quit smoking. It works by stimulating nicotine receptors in the brain, just as nicotine does, but blocks the nicotine from attaching to the receptors, reducing the pleasurable effects of tobacco as well as the desire to smoke. Because it works on the brain, Chantix may worsen preexisting psychiatric illness or cause a recurrence of past issues. However, some Chantix users who had no history of psychiatric illness and others who did not quit smoking also reported behavior or mood changes, including suicidal thoughts.
There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. The Federal Motor Carrier Safety Administration announced that the use of Chantix may adversely affect a driver's ability to safely operate a commercial motor vehicle and the FAA banned the use of Chantix among pilots and air traffic controllers.
A preliminary assessment revealed that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In October 2011, the FDA announced that two studies concluded Chantix does not lead to more hospitalizations from psychiatric events than other nicotine replacement therapies. The agency noted, however, that the studies were too small to detect rare adverse events and did not include the increased risk of psychiatric events that did not result in hospitalization.
Healthcare officials have been notified by the FDA to monitor ALL patients taking Chantix. If you have experienced behavior or mood changes, report it to your doctor and use caution when driving or operating machinery. You might also consider filing a lawsuit if you have experienced any of the following:
- Attempted suicide on Chantix
- Experienced severe Chantix aggression and caused injury to yourself or others
- Suffered severe physical injury as a result of sudden abnormal behavior
- Suffered severe physical injury or death from an accident or fall caused by seizures, black-outs, vision disturbances or other sudden problems
Chantix Heart Problems
On June 16, 2011, the US Food and Drug Administration issued a warning that Chantix may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This information will be added to Chantix physician labeling. According to the FDA, a clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo showed patients treated with Chantix suffered more cardiovascular adverse events than those treated with a placebo. The cardiovascular events included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization and new diagnosis of peripheral vascular disease. Although the number of cardiovascular events was small, the FDA notes that some events, including heart attack, occurred more frequently in patients treated with Chantix.
Meanwhile, a study published in the Canadian Medical Association Journal suggests a link between the use of Chantix and an increased risk of heart attacks and other cardiovascular events. Researchers reportedly found a 72 percent increase in the risk of cardiovascular events in patients who took Chantix compared with those who took a placebo. The study suggests that this risk is increased even in patients with no history of cardiovascular disease. According to researchers, 52 of 4,908 patients taking Chantix suffered a serious cardiac event, compared with 27 out of 3,308 who took a placebo.
Chantix Lawsuits
Lawsuits have been filed against Pfizer Inc., the maker of Chantix, alleging Chantix side effects caused users to commit or attempt suicide and that Pfizer failed to properly warn users and the medical community about the potential side effects which could increase the risk of suicide or unusual behavior changes. The lawsuits also claim that Pfizer failed to adequately research their medication.
The parents of Carter Albrecht, who was shot to death in September 2007 just a week after their son began taking Chantix, filed a lawsuit against Pfizer for not disclosing the risks of Chantix or providing adequate warning of possible side effects. According to the Dallas Morning News, Albrecht became violent toward his girlfriend and seemed confused and terrified. He banged violently on the back door of a neighbor's home and the terrified neighbor shot a warning from his rifle that accidentally killed Albrecht.
Many individual lawsuits are being filed nationwide (three lawsuits were filed in New York state court in January, 2010) and all federal Chantix lawsuits have been consolidated in an MDL that is centralized in the U.S. District Court for the Northern District of Alabama.
If you have attempted suicide or a loved one has committed suicide after taking Chantix, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Last updated on Nov-2-11 |
CHANTIX ARTICLES AND INTERVIEWS
Chantix Increases Risk for Cardiovascular Events, New Study Finds
Washington, DC: Results from a new study on the smoking-cessation drug Chantix (varenicline) show that it is associated with a small but significant increase in the risk for cardiovascular events [READ MORE]
Experts: Clinical Trials Should Have Shown Chantix Side Effects
New York, NY: Experts say that lawsuits from patients and warnings from the US Food and Drug Administration (FDA) over Chantix side effects could have potentially been avoided if clinical trials had been structured differently, Reuters reports [READ MORE]
Chantix: Parents and Police Intervened
Attleboro Falls, MA: "I started smoking when I was sixteen because I wanted to fit in," says Ryan, now 28 years old. "A few years ago I wanted to quit for health and social reasons: I started coughing and none of my friends smoked anymore, so my doctor gave me a sample package of Chantix. [READ MORE]
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