STAT (2/23, Silverman) reports that a new analysis published in Pharmacoepidemiology and Drug Safety concludes that drug-makers â€œgenerally fail to include key data that the FDA might use to assess future warningsâ€ in their reports to the agencyâ€™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 patientâ€™s age and sex. Another 47% of reports did not include the date of the adverse event. According to STAT, â€œreports involving patient deaths offered the least amount of complete information for all of the key data points.â€ A spokesperson for the FDA said the agency is â€œaware that the quality of adverse event reports may vary.â€
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