FDA: Agency Asked Pfizer To Resubmit ‘Large Number’ Of Chantix Adverse Reports

FDA: Agency Asked Pfizer To Resubmit ‘Large Number’ Of Chantix Adverse Reports

May 20th, 2011 // 11:58 am @

The Food and Drug Administration said it asked Pfizer Inc. (PFE) to resubmit a large number of adverse-event reports last year involving the company’s smoking-cessation treatment Chantix.

The FDA said in a statement posted on its website Thursday that it became aware that Pfizer and a few other manufacturers the agency wouldn’t name were submitting some adverse-event reports through “improper” channels.

There are two ways companies report adverse events to the FDA that might be product related. One way is through periodic summary reports, and another, faster way goes through a process that allows the reports to be quickly entered into FDA’s adverse event reporting system or AERS. Typically reports related to side effects that are already discussed on a drug’s label can be submitted through periodic safety-summary reports while reports that are unexpected or fatal are required to be filed as so-called 15-day reports that are filed into FDA’s AERS system.

FDA said Pfizer was asked to resubmit “thousands” of reports that were reported in periodic summary reports to the agency’s AERS system. Adverse-event reports don’t necessarily mean a product has caused a problem, but FDA uses the reports to track whether reported problems might be drug related.

In a statement, Pfizer said it “takes the safety of all patients it serves very seriously. Pfizer has complied fully with FDA requirements regarding adverse events reports it has received related to the use of Chantix.”

According to the Institute for Safe Medication Practices, a nonprofit group that monitors drug safety, there were 1,055 serious adverse-events reports related to Chantix reported in the third quarter of last year including 150 completed suicides. ISMP said the quarter’s totals included 589 serious adverse-event reports that had occurred in prior years but were entered into FDA’s adverse-event reporting database for the first time in July 2010.

ISMP reported about the increased adverse-events related to Chantix and the reasons behind it in a medication safety alert dated May 19. FDA then posted its own statement about Chantix on the agency’s website.

ISMP said prior to the third quarter, FDA’s adverse-event database had shown 37 suicides reported to the agency by Pfizer and an additional 85 reported by consumers and doctors.

Chantix carries the agency’s toughest boxed warning discussing the risk of neuropsychiatric events including “suicidal thoughts or actions.” FDA said it is continuing to monitor the drug’s safety and recently started two new safety studies with the Department of Defense and the Veterans Administration.

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FDA said the additional Chantix AERS reports “have not changed the agency’s position on the drug’s risk and benefits given that these reports were consistent with those that led to the 2009 labeling change.” Chantix was approved in 2006. FDA said it then started to receive reports of neuropsychiatric events in some patients taking the drug, which led to the boxed warning being added to Chantix in 2009.

Last May the FDA sent Pfizer a warning letter for failure to properly follow the agency’s adverse-event reporting rules for some products including Lyrica and Lipitor. Chantix was not mentioned in that letter.


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