Chantix Litigation at The Lanier Law Firm
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.
At that time, the FDA stated that it had received and was analyzing post-marketing reports of suicidal thoughts and aggressive and erratic behavior in patients, starting within days to weeks of initiating Chantix treatment, and added information about these serious events to the POST-MARKETING EXPERIENCE section of the Chantix label.
A subsequent February 1, 2008, FDA Alert heightened public health concerns when the FDA revealed, based on its safety review, that "it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms." As a result, the FDA elevated the prominence of the neuropsychiatric safety information to the WARNINGS and PRECAUTIONS sections of the Chantix label.
Symptoms outlined by the FDA include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. The FDA stated further that in most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.
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 as follows:
- Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.
- Healthcare professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.
- Patients taking Chantix should immediately report changes in mood and behavior to their doctor.
- Patients taking Chantix may experience vivid, unusual, or strange dreams.
- Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.
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). In response to 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 a loved one has used Chantix and suffered any side effects, please contact our office for a free evaluation.
Chantix Litigation Links:
FDA Information Regarding Chantix
"FAA Bans Chantix, Drug Linked to Vision, Heart Problems", Fox News, May 22, 2008
"Pfizer's Chantix Tied to 3,000 Side Effects Reports", Bloomberg, May 21, 2008