ISMP Study Shows Pfizer Failed to Report Chantix Side Effects to FDA
Pharmalot submits: Adverse event data from the third quarter of 2010 show the risks of serious psychiatric side effects of Chantix, the smoking-cessation drug, were previously underestimated because Pfizer (PFE) apparently failed to correctly submit hundreds of these episodes to the FDA, according to an analysis by the Institute for Safe Medicine Practices, a non-profit that regulary reviews the FDA adverse event database.Notably, the ISMP found 150 cases of completed suicides, some of which dated back to 2007, that were not reported promptly as suicides within 15 days as required. Instead, the drugmaker apparently coded the suicides as "expected adverse events"among 26,000 such events, and added these to a quarterly periodic report, which is how less important, non-serious side effects are sent to the FDA. What ISMP calls a "breakdown in safety surveillance"meant that, until July 2010, FDA analysts were not aware of more than half of the reported suicide casesComplete Story »
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