Chantix is a prescription medication that contains the active ingredient varenicline, which works to block nicotine from stimulating brain receptors so smokers do not experience the same sense of pleasure from smoking. Chantix is manufactured and marketed by Pfizer and is used to help people quit smoking.
The Food and Drug Administration (FDA) indicates that more than 2.3 million prescriptions were dispensed for Chantix from September 2011 to 2012.
While millions of patients counted on Chantix to help them give up their dangerous smoking habits, it turned out that Chantix subjected them to some serious potential complications. Just a year after the FDA issued a news release announcing the approval of a “novel medication for smoking cessation,” reports began to arise about patients exhibiting aggressive and erratic behavior after taking the drug. More reports of trouble followed, including evidence linking Chantix to heart problems.
Subsequent studies have confirmed the dangers of the drug, and some patients have begun filing lawsuits. If you or a loved one experienced unexpected side effects after taking Chantix, the dangerous drug attorneys at Roberts & Roberts can assess your situation and assist you in getting the compensation that you deserve.
Suicide and Mental Health Risks from Chantix
By November 2007, the FDA had received at least 39 complaints of suicides that were believed to be linked to Chantix, as well as more than 500 reports that the medication was causing suicidal thoughts.
The FDA ordered a review of the potential side effects related to erratic behavior and suicidal thoughts caused by Chantix, and the Federal Aviation Administration (FAA) soon banned air traffic controllers and pilots from taking the drug. The FAA reviewed reports of adverse events made to the FDA between May 2006 and December 2007, which showed:
- 397 cases of possible psychosis.
- 525 reports of hostility or aggression.
- 227 reports of suicides or attempted suicides.
Researchers from the Public Health Sciences division of Wake Forest Baptist Medical Center conducted a large-scale study and found that Chantix was eight times more likely to be linked to depression or suicidal behavior than other nicotine-replacement products.
At the time of its release, Chantix did not contain warnings about the potential link between the drug and suicide or mental disturbances. By June 2008, the FDA mandated that the drug carry a black box warning citing suicidal thoughts, depression and changed behavior as possible side effects. This is the highest level of warning.
Unfortunately, the black box warning came too late for those who had already been affected by the drug.
Chantix and Heart Problems
Within 18 months after Chantix was released, the FDA had received at least 224 complaints indicating that the medication had caused heart problem.
A Canadian Medical Association Journal study of more than 8,216 people involved in clinical trials found that smokers who were prescribed Chantix had a 72 percent increase in the risk of a serious, and perhaps fatal, cardiovascular event, such as a stroke or a heart attack. Even those without pre-existing heart conditions faced a similar increased risk.
A similar study took place in the U.S. and included a review of more than 7,000 smokers. The U.S. study showed that people who took Chantix for three or more months experienced cardiac events and developed problems much more frequently than those who took a placebo. Based on the results of this study, the FDA issued a warning about the heart risks of Chantix. Pfizer was also ordered to conduct additional safety studies to develop a better understanding of the dangers associated with Chantix.
When Pfizer completed this study, the FDA issued another safety announcement in December 2012. While the FDA clarified that the increased risk of cardiac events had not shown up as statistically significant in the studies, it said that the data “consistently showed a higher occurrence of events in patients using Chantix, which makes it seem more likely that it is related to the drug and not purely a chance finding.”
Have You Suffered Chantix Side Effects? Talk to Our Dangerous Drug Lawyers
While few drugs are completely free of side effects, patients must be informed about the risks they take and must be able to make informed choices by being given all of the information.
When a drug causes unexpected side effects or illnesses, those prescribed the medication may hold the drug manufacturer responsible. This means that if you can show that Chantix caused you or a loved one to develop a heart condition, erratic behavior or suicidal tendencies, you could be entitled to compensation for your losses.
Many people have already taken action against Pfizer because of problems with Chantix. You too should get legal help to protect your rights.
The dangerous drug attorneys at Roberts & Roberts are currently investigating claims related to Chantix. For a free, confidential review of your claim, call us today at 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.
- FDA Drug Safety Communication – Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events
- Federal Aviation Administration – Anti-Smoking Medicine Chantix Banned
- Reuters – New study says Chantix raises suicide risks
- New York Times — F.A.A. Bans Antismoking Drug, Citing Side Effects