Chantix, or Varenicline Tartrate (approved by the Food and Drug Administration (FDA) in May 2006) is a smoking cessation drug manufactured and marketed by Pfizer. It is prescribed to patients seeking to end their smoking addiction by reducing cravings and decreasing the pleasurable effects of cigarettes and other tobacco products. According to Pfizer, at least 3,000,000 Americans take Chantix.
The FDA received reports of 37 suicides and more than 400 incidents of suicidal type behavior in 2007 that may have been linked to Chantix. As a result, the FDA began an investigation into those reports. According to the FDA, a link between Chantix and serious psychiatric complications is probable. It is also thought that Chantix may worsen pre-existing psychiatric illness or cause a recurrence of past psychiatric issues.
On November 20, 2007, the FDA first informed the public about the possibility of serious neuropsychiatric symptoms in the FDA Early Communication About an Ongoing Safety Review. Pfizer added information about these serious events to the label of Chantix in the POST-MARKETING EXPERIENCE section.
On February 1, 2008, the FDA revealed that, based on its safety review, "it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms." As a result, the FDA placed the neuropsychiatric information in the WARNINGS and PRECAUTIONS section of the label. Specifically, the warning states:
Patients who are attempting to quit smoking with CHANTIX should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.
On May 16, 2008, the FDA further updated its Public Health Advisory and issued a medication guide to alert patients, caregivers, and healthcare professionals to important changes to the Chantix label to include warnings about the possibility of severe changes in mood and behavior in patients taking Chantix:
Most recently, on May 22, 2008, the Institute for Safe Medicine Practices ("ISMP") released a study on Chantix. The study, "Strong Safety Signal Seen for New Varenicline Risks," was authored by Thomas J. Moore, Michael R. Cohen and Curt D. Furberg.
The ISMP authors noted that "[f]rom May 2006 through December 2007, the FDA had received 227 domestic reports of suicidal acts, thoughts or behaviors, 397 cases of possible psychosis and 525 reports of hostility or aggression. These totals included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination."
Even more alarming, the authors described reports of a greater spectrum of side effects beyond suicide and depression, including 224 reports of potential cardiac rhythm disturbances, 86 cases of seizure, 148 reports of vision problems, and 544 reports of loss of glycemic control (diabetes). According to Furberg and his co-authors, Chantix accounted for 988 reports of serious injuries in the last quarter of 2007, which was more than any other drug.
In response to the ISMP study on Chantix, the Federal Aviation Administration (FAA) issued an immediate ban on the use of Chantix by pilots and air traffic controllers.
If you or your loved one used Chantix and you have questions, please contact us using the form below for a free consultation.
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