Chantix side effects and adverse event reports outlined by non-profit group
A report released last week by a nonprofit watch dog group renewed attention on Chantix side effects, and raises further questions about the adequacy of the current warnings. According to the report, the FDA has received information about hundreds of serious problems associated with the anti-smoking drug, including suicides, homicidal thoughts, paranoia, hallucinations, falls and potentially fatal heart problems.
Researchers from the Institute for Safe Medication Practices reviewed reports of Chantix side effects received by the FDA between May 2006 and December 2007. Over the 20 month period, the regulatory agency received reports of:
- 227 Suicides or Suicide Attempts
- 297 Cases of Possible Psychosis
- 525 Reports of Hostility or Aggression
- 173 Accidental Injuries, including road accidents and falls
Some of the other problems noted include reports of heart rhythm disturbances, heart attacks, seizures and diabetes. The numbers presented in the report likely represent only a small fraction of the true number of Chantix problems, as it is generally held that adverse events reported to the FDA only represent about 1% to 10% of all occurrences.
The independent report provides strong evidence that the risks associated with Chantix treatment have been underestimated. When Pfizer introduced Chantix they were not providing any warning to users or the medical community about the potential psychiatric side effects, including an increased risk of suicidal thoughts or behavior. In November 2007, vague information was first added to the label about potential psychiatric side effects. However, the warnings were deminished by conflicting and confusing language.
In January 2008, the label was updated again to include more detailed information about Chantix side effects, such as suicidal thoughts, severe changes in mood and aggressive behavior. The FDA also required Pfizer to develop a medication guide for individuals filling the prescription to include information highlighting the warnings about psychiatric symptoms and the possible risk of suicide on Chantix.
In response to the Institute for Safe Medication Practices’ report, Pfizer issued a statement last week indicating that they believe the current warnings accurately reflect Chantix’s safety profile. However, many experts disagree and feel that stronger warnings should be placed in a “black box” prominently displayed on the label.
The health concerns outlined by the Institute’s report also prompted the Federal Aviation Administration (FAA) to issue a Chantix ban for all pilots and air traffic controllers. Approximately 150 pilots and 30 air traffic controllers who are currently taking the drug will no longer be able to use it because of concerns surrounding the erratic, suicidal and homicidal behavior outlined in the report.
CHANTIX SIDE EFFECT LAWSUITS
The Chantix lawyers at Saiontz, Kirk & Miles, P.A. are investigating potential lawsuits on behalf of clients who have suffered severe physical injury or death from a suicide or suicide attempt. If you, a friend or family member have experienced Chantix side effects, request a free consultation and claim evaluation.
