August 13, 2015 — About 10% of reports involving serious or unexpected side effects from a medication are not submitted to the FDA within 15 days as required by law, according to a study published in JAMA Internal Medicine.
Conclusions were based on data from 1.6 million reports in the FDA Adverse Event Reporting System (FAERS) from 2004-2014. About 160,000 reports were not filed on time, including 40,500 reports involving death of the patient.
Serious events involved life-threatening side effects, birth defects, disability, hospitalization, or death. Unexpected events involved side effects that were not included in the drug label.
FAERS is a critical tool for monitoring the safety of medications, but it only works if doctors and drug-makers report side effects. Dr. Rita Redberg wrote in an accompanying editorial:
“Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death … Clearly, the lack of consequences contributed to a lack of deterrence for these illegal and dangerous delays.”
Some say the findings should not come as a surprise because drug-makers routinely outsource adverse-event monitoring to the lowest bidder. Another concern is that even when reports are filed on time, the FDA does not release them publicly for at least seven months.
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