The United States regulations require drugmakers to report any serious and unexpected adverse events from their drugs to the Food and Drug Administration within 15 days. However, researchers at the University of Minnesota found that the drugmakers delayed reporting such incidents, including death, in nearly 10% of cases. Besides death, reports on serious adverse events from drugs also could involve cases that were life-threatening, required hospitalization, resulted in disability or in birth defects.
The study suthors said, "Strikingly, AEs (adverse events) with patient death were more likely to be delayed. It is possible that manufacturers spend additional time in verifying reports concerning deaths, but this discretion is outside the scope of the current regulatory regime."
AdvertisementRita Redberg, the editor of JAMA Internal Medicine, said, "The delays exposed other patients to serious risks. Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death. Physicians who report on their patients' adverse reactions to drugs should do so directly to the FDA, rather than to the manufacturer."
For the study, Pinar Karaca-Mandic and her colleagues examined serious adverse event reports submitted to the FDA between January 2004 and January 2014. They found that out of the 1.6 million reports, 160,383 were not received by the FDA within the 15-day time window. Of those, 40,464 involved deaths of the patients.
The study appeared in JAMA Internal Medicine.
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