Pfizer may have intentionally misreported hundreds of incidents detailing Chantix suicide risks and other serious drug 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 drug side effects, the Institute for Safe Medication Practice reports. Last year, the FDA asked Pfizer to resubmit thousands of drug side effect reports after it had done so in an improper format; they could not be properly inputted in the agency's tracking system.
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.
Drug Side Effect "Black Box Warning"
The FDA requires a black box warning for one of the following situations:
The medication can cause serious undesirable effects (such as a fatal, life-threatening or permanently disabling adverse reaction) compared to the potential benefit from the drug. Depending on your health condition, you and your doctor would need to decide if the potential benefit of taking the drug is worth the risk.
A serious adverse reaction can be prevented, reduced in frequency, or reduced in severity by proper use of the drug. For example, a medication may be safe to use in adults, but not in children. Or, the drug may be safe to use in adult women who are not pregnant.
As a result of this information and the growing attention paid to Chantix suicide risks, France has pulled the drug from its government insurance program. MSNBC reports the FDA has said that this information changes nothing. 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 drug 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.
South Carolina Drug Side Effect Attorneys
Proving liability in a drug side effect claim requires the shill and experienced only possessed by a few personal injury lawyers. The Clore Law Group has successful represented clients in complicate litigation matter like this. Contact them today if you or a loved one was injured by a drug side effect.