FDA Warns Pfizer for Unreported Drug Complaints

By Matthew Perrone (AP)

WASHINGTON — Federal regulators have warned Pfizer Inc. for failing to promptly report complaints with its drugs that may have involved serious injury.

In a warning letter obtained Wednesday by The Associated Press, the Food and Drug Administration cites a number of product complaints which were not reported to government regulators within the required 15 days.

In some cases, Pfizer failed to report the adverse events all together, including reports of serious side effects with the cholesterol drug Lipitor and the antiseizure drug Lyrica.

FDA inspectors found the unreported complaints during a routine inspection at the company’s New York headquarters last summer. The problems outlined in the May 26 warning letter are not new. Inspectors cited the company for similar violations in 2004 and 2006.

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