FDA Requires Behavioral Warnings on Chantix Packages
May 27, 2010
Chantix, an oral non-nicotine prescription drug produced by Pfizer, is used to help patients quite smoking. In November 2007, the FDA put out the first warning about the severe changes in mood and behavior to alert patients, caregivers, and healthcare professionals about these changes to Chantix prescribing information. Pfizer updated their packaging to include warnings about the possibility of severe mood changes and behavior in patients taking Chantix. The FDA highlighted that patients should tell their physician about any previous history of psychiatric illness before taking Chantix as Chantix may heighten any psychiatric illness even if it is under control and may cause old psychiatric issues to reoccur such as Chantix Suicide. Healthcare providers should be alert to and monitor changes in mood and behavior with their patients. In most cases, psychological symptoms developed during Chantix treatment, but others developed following withdrawal of Chantix therapy. Patients taking Chantix should report any changes in mood and behavior to their physician. In addition, patients may experience vivid, unusual, or strange dreams. The warning also includes that patients may experience impairment of the ability to drive or operate heavy machinery. The FDA also wrote that the link between Chantix and these symptoms was unclear. The FDA and Pfizer began to work on a Medical Guide for these patients.
FDA Now Requires a Black Box Warning for Chantix
In August of 2009, the FDA again revised the safety label on Chantix regarding the risk for serious neuropsychiatric events. This “black box” warning was based on post-marketing reports of changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal thoughts, hostility, agitation, anxiety, and panic, as well as suicidal thoughts, suicide attempt, and completed suicide. These behaviors have occurred in patients with and without preexisting psychiatric disease. The FDA noted that patients with serious psychiatric illnesses (i.e. schizophrenia, bipolar disorders, and major depressive episodes) were excluded from clinical trials therefore the drug safety in the subpopulation had not been evaluated. The FDA also warned that car crashes, near-miss accidents, and other unintentional injuries have occurred with individuals taking Chantix. These individuals reported drowsiness, dizziness, loss of consciousness, or difficulty concentrating resulting in the inability to perform current activities. Medical guides are now available to inform doctors and patients of Chantix side effects as well as its generic versions (i.e. Zyban). The FDA urges healthcare providers and patients to report Chantix side effects to the FDA by way of the MedWatch program.
If you have experienced depression, mania, hallucinations, homicidal thoughts, suicidal thoughts or any other Chantix side effects you may be entitled to financial compensation. Chantix lawsuits are currently being filed across the country.
Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research. Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising. To learn more about Chantix Side effects or Chantix Suicide please visit www.ConsumerInjuryLawyers.com