Approved by the fda in may 2006 as a smoking cessation drug, problems quickly arose
- In May 2006, The FDA Approves New Drug for Smoking Cessation the FDA approved Chantix as a smoking cessation drug to help smokers ages 18 and older stop smoking. The drug received a priority review because of its significant potential benefit to public health. Chantix was reviewed in six months rather than the regular review time of 10 months.
- On September 24, 2007, a CBS TV affiliate in Dallas-Fort Worth ran a story titled Chantix: Miracle drug or dangerous problem? after a well-known local musician was killed in an incident believed to be related to erratic behavior associated with Chantix.
- On November 20, 2007, Early Communication About an Ongoing Safety Review FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
- On January 18, 2008, Pfizer updated the Chantix label in the U.S. to include a warning that 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 February 1, 2008, the FDA issued an Alert on the Safety of Chantix to clarify its findings, noting that “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”
- On May 21, 2008, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The study specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix.
- On May 23, 2008, less than 48 hours after Institute for Safe Medication Practices released their report, the Federal Aviation Administration (FAA) banned Chantix use by pilots and air traffic controllers. F.A.A. spokeswoman, Laura Brown, said the decision was based on emerging data on the drug, including a report from a watchdog group, the Institute for Safe Medication Practices, linking Chantix to a wide array of health and safety problems. They include accidents and falls, potentially lethal heart rhythm disturbances, heart attacks, seizures, diabetes and various psychiatric disturbances.
Do you have a Chantix claim?
If your loved one has suffered a serious injury or death as a result of a side effect of Chantix, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.
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