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Many drug-makers filing incomplete side effect reports to FDA, analysis concludes


STAT (2/23, Silverman) reports that a new analysis published in Pharmacoepidemiology and Drug Safety concludes that drug-makers “generally fail to include key data that the FDA might use to assess future warnings” in their reports to the agency’s Adverse Event Reporting System. According to the analysis, 40% of expedited reports and 51% of periodic reports filed by drug-makers to the FDA were incomplete, with 38% lacking the patient’s age and sex. Another 47% of reports did not include the date of the adverse event. According to STAT, “reports involving patient deaths offered the least amount of complete information for all of the key data points.” A spokesperson for the FDA said the agency is “aware that the quality of adverse event reports may vary.”

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