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Pfizer may have intentionally misreported hundreds of incidents detailing Chantix suicide risks and other serious side effects, according to a recent report by non-profit pharmaceutical watchdog.
Though Pfizer did report suicides and suicide attempts linked to its smoking-cessation drug, the incidents were improperly buried amongst tens of thousands of reports describing minor side effects, the Institute for Safe Medication Practice reports.
Last year, the FDA asked Pfizer to resubmit thousands of side-effect reports after it had done so in an improper format; they could not be properly inputted in the agency's tracking system, reports MSNBC.
Under FDA guidelines, non-serious drug side effects are to be reported each quarter, whereas serious and fatal risks must be reported within 15 days. According to the study, Pfizer reported 150 Chantix suicide events as "non-serious," which more than doubles previously known suicides, reports The Day.
As a result of this information and the growing attention paid to Chantix suicide risks, The Day notes that France has pulled the drug from its government insurance program.
However, the FDA has said that this information changes nothing, reports MSNBC. It has already demanded more clinical trials, and as of 2009, Chantix packaging is marked with a "black box warning," which warns of suicide.
This does not mean that this new evidence is useless.
It can be particularly beneficial for those who suffered from serious side effects prior to 2009 and are suing the company. Indeed, there's an argument to be made that Pfizer knew about Chantix suicide risks as early as 2006-7, and that it was negligent in warning consumers.