Chantix Suicide and Stevens-Johnson Syndrome Warnings Issued in Canada

Canadian health officials have released new, more stringent, health warnings regarding the side effects of Chantix; which could include an increased risk of suicide and a potentially life-threateneing skin reaction known as Stevens-Johnson syndrome

Health Canada, which is the regulatory health department in Canada, released a public communication and sent a letter to healthcare professionals on June 3, alerting them to the fact that it had strengthened health risk warnings on Champix, which is sold as Chantix in the United States.

The additional information includes a boxed warning regarding the risk of neuropsychiatric side effects, such as changes in mood and behavior, and also includes a warning of serious allergic and skin reactions, which can include Stevens-Johnson Syndrome.

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“There have been continuing Canadian and International post-marketing reports of serious neuropsychiatric symptoms, such as depressed mood, agitation, aggression, hostility, changes in behavior, suicide related events and worsening of pre-existing psychiatric disorder in patients treated with Champix,” Health Canada warned. “These events have occurred in patients with and without pre-existing psychiatric disorder.”

This is not the first time Health Canada has warned users about the risk of suicide with Champix. In January 2009, the health officials issued a reminder to Canadians who were taking the drug or considering the smoking-cessation aid, urging users and their family members or loved ones to be aware of any unusual thoughts or behavior and to immediately stop using the drug if they experienced problems.

Chantix (varenicline) was approved in the United States by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the Chantix side effects have been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric problems, which have resulted in fatal or catastrophic injuries for many users.

Stevens-Johnson Syndrome (SJS) is a severe skin reaction that can occur as a side effect of several medications. It is highly debilitating and causes the skin to burn from the inside out, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.

In the United States, the FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 about the potential psychological side effects. Pfizer has also been required to conduct clinical trials providing more data on how often neuropsychiatric symptoms and suicide with Chantix occur and what conditions cause them.

There have been several high-profile suicides on Chantix that have garnered media attention, including a Dallas musician and a Georgia politician.

Lawsuits over Chantix have been filed in state and federal courts throughout the United States on behalf of individuals who have suffered injuries from the neuropsychiatric side effects of Chantix, skin reactions from Chantix and for family members of individuals who have committed suicide on Chantix.

In October 2009, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal Chantix lawsuits in the U.S. District Court for the Northern District of Alabama. According to a pretrial scheduling order issued earlier this year, the first Chantix trial is unlikely to reach a jury until at least 2012.


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