Delays found in drugmakers reporting of serious adverse reactions
Drugmakers have delayed reporting serious and unexpected “adverse events” from their drugs, including death, in nearly 10 percent of cases, a study said Monday.
US regulations require drugmakers to report such incidents to the Food and Drug Administration within 15 days, but researchers at the University of Minnesota found that they delayed doing so in about one in 10 cases.
“Strikingly, AEs (adverse events) with patient death were more likely to be delayed,” the study’s authors said.
“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.”
The study appeared in JAMA Internal Medicine, whose editor 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,” wrote the journal’s editor, Rita Redberg.
She suggested that 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 co-authors examined serious adverse event reports submitted to the FDA between January 2004 and January 2014.
They found that of 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 patients.