FDA Keeps Suicide Warning and Add Alcohol and Seizure Warning on Chantix

Chantix, (varenicline), is a nicotine-free pill that is supposed to assist in smoking cessation. While Chantix users might reasonably expect some nausea and sleep problems, Chantrix is also believed to cause psychiatric problems that can lead to suicide.

By 2009, the FDA released a warning about the risk of serious mental health events linked to the use of Chantix. These mental health events include risk of depression, hostility, and suicidal thoughts. A study published in the Public Library of Science Journal (PLoS), suggested that Chantix was eight times more likely to be linked to suicidal behavior than other nicotine replacement products.

Between 2007 and 2013, the Institute for Safe Medication Practices indicated that Chantix was associated with at least 2,748 adverse event reports submitted to the FDA involving suicide, self-injury or homicidal ideation. The next closest medication, which was the asthma drug Singulair, accounted for 835 cases during that same period; less than one-third the number linked to Chantix.

With the mounting proof that Chantix has severe side effects that were not disclosed to the public, Chantix lawsuits have been filed based upon the failure of Pfizer (the manufacturer) failing to warn patients or the medical community of the side effects of Chantix – including those who have committed or attempted to commit suicide while on Chantix.

In the last few years, there have been some settlements of the over 3,000 claims that have been filed. These first grouping of settlements occurred in a federal Multi-District Litigation in the U.S. District Court for the Northern District of Alabama. As of April 2014, only about 250 lawsuits remain unresolved. Pfizer had allocated $273 million to resolve over 2,000 lawsuits, and $15 million to resolve the rest.

In addition to adverse mental health effects, the FDA recently released a safety announcement on March 9, 2015 that Chantix has been associated with seizures and that some patients who drink while taking the drug may become aggressive, black out, or suffer from amnesia.

With this recent additional warning, it is likely that more lawsuits are on the horizon against Pfizer for users who have experienced adverse health effects.

If you or someone you know have experienced adverse health effects from using Chantix or any other pharmaceutical drug, you should contact Jacoby & Meyers. The attorneys associated with Jacoby & Meyers are experienced in litigating pharmaceutical drug cases and can provide you with the type of representation you deserve for your case.

Alexandra Bhatti, student intern Jacoby & Meyers