Class Action Lawsuit

Chantix Side Effects Lawsuits

Details: Parent Category: Lawsuit News Alerts; Category: Defective Product Lawsuit News And Recall Lawyer

Chantix Side Effects Lawsuits

Chantix was one of twenty medications that encountered a safety review by the Food & Drug Administration in early June 2009. Later in June the FDA required that Pfizer display a boxed warning prominently on the medication that warns about the risk of depression, behavior changes, hostility and suicidal thoughts.

The FDA said that they based the new black box warning on a review of reports submitted to the agency’s Adverse Event Reporting System from the time the drug was marketed and also on analysis of information from clinical trials and scientific readings. As of July 2009 98 suicides and 188 attempted suicides among Chantix patients were reported to the FDA. In many of the cases the FDA stated that the problems began not long after the patients began using the medication and ended when the medication was stopped. They also stated that a portion of the problems could have been a result of nicotine withdrawal although many of the events that were reported occurred while the patients were still smoking.

Chantix side effects lawsuits are well documented so it should be no surprise that the drug made the FDA’s list. The anti-smoking drug was approved in 2006 and then it was brought up in 2007 by the FDA in a discussion about the emerging safety concern which linked using Chantix to suicide reports, suicidal thoughts and sudden change in behavior. The FDA issued a statement in February 2008 which suggested that it is “increasingly likely that there may be an association between Chantix and serious neuropsychiatric side effects symptoms.” Also in 2008 Pfizer prioritized the importance of safety information regarding suicidal thoughts and other problems to the prescribing information.

Chantix is now being reviewed by the Food and Drug Administration for a possible association with accidential injury, vision impairment and other problems. The review was prompted by accident and vision loss of hundreds of Chantix patients.

The institute for Safe Medicine Practices published a report last year which found that 1001 reports were received by the FDA stating serious adverse events in connection with Chantix in the first three months of 2008. According to the institute, as of 2008 the side effect reports contain 52 cases that involved blackouts, 50 deaths, and 15 undesirable events that were linked to road traffic accidents.

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