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Steven J. Klearman
Steven J. Klearman
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Study: Serious Drug Side Effects Not Reported To FDA In Time

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Companies are failing to report an estimated one in ten serious and unexpected medication side effects to the FDA within 15-days, as required by federal regulations, according to a new study.

Moreover drug manufacturers are even less prone to disclose adverse events within that same period when a patient dies in comparison to adverse events that are not fatal, according to analysis of 1.6 million side effect reports submitted to the agency between the years of 2004 to 2014.

To ensure patient safety, it is critical for timely reporting, said Pinar Karaca-Mandic, senior aothour and researcher at the University Of Minnesota School Of Public Health in Minneapolis.

Drug manufacturers, under U.S. regulations, are required to notify the FDA when it becomes aware of serious complications associated with disabilities, birth defects, deaths, hospitalizations and any previously unknown side effects, faster than minor complications already highlighted on the drug label.
The FDA needs to step up its enforcement of reporting requirements to ensure patient safety.

You can read more about the study here, which was published online July 27 as a research letter in the journal JAMA Internal Medicine. Patients can report serious problems to the FDA directly.