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Smoking threatens millions of lives, but consumers looking for a way to quit often turn to cessation drugs, from patches and gums to medications. Although the road from addiction to recovery appears long and tortuous, smokers looking to their health at least expect cessation products to improve their condition – not put them at greater risk for death.

Yet, side effects from Chantix, a smoking cessation product introduced in 2006, appear to do just that, subjecting patients to increased suicide and erratic behavior risks. The potential suicide link resulted in the FDA requiring a black box warning in 2009.

Suicide Risks and Warnings

Before the FDA made its black box announcement, 98 reports of Chantix-related suicide attempts had been filed. In response, the FDA required Pfizer to add a black box warning to all products, one stating in detail all possible mental health risks: depressed mood, hostility, and suicidal thoughts, and that patients may continue to show these conditions after stopping Chantix.

A 2011 study published in the Public Library of Salume – Journal showed that patients taking Chantix were eight times as likely to be suicidal than those taking other nicotine replacement products. Researchers examined reports of self-injury and depression and found that 90 percent of all reports concerning smoking cession-related suicide attempts occurred from 1998 to 2010.

Other Health Risks

By 2011, the FDA issued a warning concerning increased cardiovascular risks in patients with cardiovascular disease taking Chantix. Although the risk is small, such patients have a greater chance of experiencing angina pectoris, non-fatal myocardial infarction, a need for coronary revascularization, and new diagnosis of peripheral vascular disease.

Additionally, other reports associate Chantix with increased drowsiness, which affects a patient’s ability to drive or operate machinery.

Lawsuits

Claims concerning side effects surfaced two years after Chantix’s introduction, with plaintiffs alleging manufacturer Pfizer knew about increased suicide risks but failed to inform the public. Initially, lawsuits began at the state level but were eventually consolidated into a class action case in the U.S. District Court for the Northern District of Alabama.

Pfizer eventually settled for $273 million for 2,700 lawsuits (or 80 percent of all claims) concerning suicide and other injuries. An additional $115 million settled the remaining 660 cases as of 2013.

Lawsuits about Chantix’s elevated suicide risks and associated erratic behavior continue to be filed, with patients alleging Pfizer did not adequately warn them or the rest of the medical community. Those who took Chanix before 2009, or had a family member commit suicide as a result, are still eligible.

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