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Though the FDA is downplaying its request that Pfizer re-submit thousands of adverse event reports, according to a study done by the non-profit Institute for Safe Medication Practices (ISMP), the manufacturer's lack of compliance with reporting rules hid 150 Chantix suicides.
The catch? The majority of those suicides occurred prior to 2009, when Chantix became affixed with the agency's strict "black box warning."
For those GCs not in the pharmaceutical industry, drug manufacturers are required to file quarterly reports detailing non-serious side effects. However, serious adverse events are to be reported directly into the FDA's electronic Adverse Events Reporting System within 15 days so that the agency can more promptly respond.
According to the ISMP, prior to Pfizer's re-reporting, 589 serious adverse events were catalogued as non-serious, and subsequently buried amongst thousands of other insignificant events.
150 of those events were completed Chantix suicides. The rest were reports of attempted suicides, suicidal thoughts, and severe psychotic reactions, reports MSNBC.
Pfizer is getting some flack from the FDA, with Dow Jones reporting that evidence of new Chantix suicides does not change the agency's position on the drug, which already warns of suicide risks.
However, corporate counsel should still be worried about new and existing Chantix lawsuits.
For Pfizer to report 150 suicides as non-serious side effects is, at the very best, questionable. At the worst? It's prime evidence that the company tried to cover up the number of Chantix suicides so that it could continue to market its smoking cessation drug to the masses.