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Drug makers’ adverse event reports are often incomplete, US report finds

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h651 (Published 04 February 2015) Cite this as: BMJ 2015;350:h651
  1. Michael McCarthy
  1. 1Seattle

Drug manufacturers’ reports of adverse drug events are often incomplete, lacking such basic information as the patient’s age or gender or the date of the event, a US investigation by an independent drug safety group has found.

Researchers from the Institute for Safe Medication Practices looked at the quality of reports made to the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) over one year to the first quarter of 2014.1 During that period 847 039 reports were made to the system, including reports of 45 688 patient deaths from US sources and 41 884 deaths from foreign sources.

FAERS reports come from two main sources: from consumers or healthcare providers, who voluntarily submit reports either directly to the Food and Drug Administration (FDA) or to the drug makers; or from the drug makers, who are required by law to submit …

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