Chantix Attempted Suicide
In May 2006, when the FDA approved the drug Chantix (varenicline) to help people stop smoking cigarettes, they announced in a press release that the effectiveness of the medication was demonstrated in six clinical trials.
Only a few months after the drug became available to the public, however, reports started coming in about people suffering from Chantix attempted suicide. Many of these patients had no history of psychological problems. As early as November 2007, the FDA issued a safety communication for the drug, stating they were evaluating postmarketing reports of suicidal thoughts.
Early reports of serious Chantix side effects
In that 2007 communication, the FDA recommended that healthcare providers monitor patients taking Chantix for behavior and mood problems. Then, in February 2008, the agency stated that it was requiring new safety warnings on the product label. In a press release, the FDA noted that, “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” These included side effects like Chantix depression, behavioral changes, and suicide.
In the first quarter of 2008, the Institute for Safe Medication Practices (ISMP) claimed that varenicline accounted for more reports of serious injuries than the 10 best-selling brand name prescription drugs combined. According to their report, the FDA received over 1,000 reports of serious Chantix side effects, including 50 deaths. These were similar to reports from the last quarter of 2007, which numbered 998, with 78 deaths.
In July 2008, the first lawsuit related to Chantix suicide was filed in Indiana federal court.
Chantix attempted suicide
In examining how Chantix may increase the risk of attempted suicide, researchers point to the way the drug works in the brain. Nicotine, the addictive drug in cigarettes, creates good feelings in smokers by binding to receptors in the brain that stimulate the release of dopamine—a neurotransmitter that is linked to motivation and reward.
Chantix binds to those same receptors in the brain, blocking the ability of nicotine to activate them, and reducing the sense of reward and satisfaction obtained from smoking. Researchers theorize that the drug lowers the overall levels of dopamine in the brain, which could cause some individuals to experience mental problems
Study confirms connection with Chantix depression
In July 2009, the FDA notified healthcare professionals and patients that they were requiring Chantix manufacturers to add a black-box warning highlighting the risk of neuropsychiatric side effects, like Chantix depression, mood changes, and Chantix attempted suicide. In October of the same year, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal Chantix lawsuits in a single court in Alabama.
In 2011, the scientific journal PLoS One published a study concerning side effects of Chantix. Researchers looked at adverse event reports between 1998 and 2010 and found nearly 3,000 submissions involving depression and suicide—many more reports than those associated with other smoking-cessation products. The researchers concluded, “The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation.”
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