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FDA Warns Pfizer for Failing to Report Drug Side Effects

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June 10, 2010

The U.S. Food and Drug Administration (FDA) sent a warning letter to Pfizer, Inc. for failing to report potentially serious adverse side effects of its pharmaceutical drugs.

In a May 26 letter to Jeffrey Kindler, Pfizer Chief Executive Officer, the FDA cites a number of instances in which the drug maker failed to report potentially serious adverse drug side effects associated with its products within the required 15 days to federal regulators. In some cases, Pfizer failed to report the adverse events at all.

Examples the FDA referred to included side effects from the prescription erectile dysfunction drug Viagra, cholesterol-reducing drug Lipitor and the anti-seizure drug Lyrica.

Pfizer repeatedly failed to report complaints about vision problems caused by Viagra, sometimes misclassifying or downgrading the seriousness of the complaint.

"FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated," said Ronald Pace, director of the New York FDA office, in the letter.

The FDA found the lapses while performing a routine inspection of Pfizer’s headquarters in New York over six weeks in the summer of 2009.

According to an Associated Press article, the FDA cited Pfizer for similar violations in 2004 and 2006. Yet between March 2006 and July 2009, the company still submitted about 13% of adverse event reports late.

“We will continue to work closely with FDA to address these issues to the Agency’s full satisfaction and to assure optimal surveillance and reporting of postmarketing adverse events,” Pfizer said in a statement in response to the FDA’s letter. “We are committed to full compliance and timely and accurate submission of individual adverse event reports.”

Pfizer must correct the problems or submit a plan to correct the violations within 15 days to remain in compliance or the company may face penalties.