According to a new report, both Pfizer and federal regulators ignored calls for the smoking cessation drug Chantix to be tested on users with mental illnesses. Critics now argue that such pre-market testing may have revealed the serious psychological Chantix effects, which have allegedly resulted in hundreds of suicides and suicide attempts.
According to a report issued by Fairwarning.org, Pfizer won approval to market Chantix in 2006 through an expedited process over the objections of some of the FDA’s own drug safety reviewers, who said that the drug should be tested on people with psychological problems.
A disproportionate number of smokers suffer from depression, anxiety and other psychological issues, yet the report suggests that Pfizer did not adequately test the side effects of Chantix on this population of potential users.
Chantix (varenicline) was approved by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the drug has been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric side effects, which have resulted in fatal or catastrophic injuries for many users. Since Chantix was released it has been linked to nearly 100 suicide deaths, 200 attempted suicides and 5,000 psychiatric events.
Officials from the FDA and Pfizer deny that there were any missteps in the approval process for Chantix, despite the fact that the FDA ordered Pfizer to conduct clinical trials on the mentally ill in 2009, three years after the drug was approved. As early as 2008, some attorneys investigating Chantix suicide lawsuits raised questions about why the drug had not been tested on people with psychological problems.
The FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 about the potential psychological side effects. Following the rising tide of suicide reports, the FDA ordered the new clinical trials in hopes of gaining more data on how often neuropsychiatric symptoms with Chantix occur and what conditions cause them.
A growing number of individuals throughout the United States have filed a Chantix lawsuit against Pfizer. All of the complaints involve similar allegations that Pfizer failed to adequately research the effects of Chantix or warn about the increased risk of unusual and aggressive behavior, such as suicide and unexpected acts of violence.
The federal Chantix litigation has been consolidated as part of an MDL, or multidistrict litigation, for pretrial proceedings before U.S. District Judge Inge P .Johnson in the Northern District of Alabama. The parties have been directed by Judge Johnson to submit a joint proposal by February 1, 2011 regarding the process for selecting a pool of initial cases that will be eligible for case-specific discovery and trial, if necessary.
These early cases, which are known as Chantix bellwether lawsuits, are used to help the parties gauge strengths and weaknesses of their cases, and may lead to an eventual Chantix settlement or other resolution for the litigation.