Chantix Suicide and Side Effects
Reports of serious Chantix side effects, including a possible link between use of Chantix and suicide resulted in the US Food and Drug Administration (FDA) issuing a black box warning for the smoking cessation drug. Chantix lawsuits have been filed, alleging patients who used Chantix were harmed by the medication.
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Chantix Suicide WarningsIn July 2009, the FDA announced an update to Chantix (known generically as varenicline) warnings, alerting patients to the risk of serious mental health events linked to use of the smoking cessation drug. Pfizer, maker of Chantix, was required to put a Boxed Warning on the Chantix label, highlighting the risk of depressed mood, hostility and suicidal thoughts when using the medication. At the time of the announcement, the FDA noted that patients should weigh the risks of continuing smoking against the risks of using Chantix to quit. The FDA warned, however, that some patients experienced unusual changes to their mood or behavior even after stopping the medication.
In addition to the Boxed Warning, the FDA required Pfizer to conduct a clinical trial to determine how frequently mental health symptoms occurred in patients using Chantix to quit smoking.
Chantix SuicideWhen the FDA made its announcement in 2009, it had received 98 crude reports of completed suicide associated with Chantix (a crude report means the FDA had not examined each report in depth to ensure there were no duplicates). It had a further 188 crude reports of suicide attempts.
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.
A study published online in the Public Library of Science journal PLoS One (11/11), however, suggests that use of Chantix was eight times more likely to be linked to suicidal behavior than other nicotine replacement products. The study analyzed reports of serious self-injury or depression associated with the use of Chantix. Furthermore, the study found that 90 percent of all reports of suicide linked to the use of a smoking cessation product from 1998 through 2010 were linked to the use of Chantix, even though Chantix was only on the market from 2006.
Chantix Heart AttackOn 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 was 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.
Chantix LawsuitsChantix lawsuits have been filed against Pfizer Inc, alleging the smoking cessation drug caused users to commit suicide or attempt suicide, and that Pfizer did not adequately warn patients or the medical community about the risk of side effects. Patients who used Chantix and attempted suicide before mid-2009 while still taking the medication may be eligible to file a lawsuit. Similarly, family members whose loved ones committed suicide while taking Chantix might have grounds for a lawsuit.
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