In some cases, however, the side effects may not be listed at all.
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“There is no question that it is critical that manufacturers report adverse events, accurately attributed to their respective products, in a timely manner to ensure patient safety”, Getz, who wasn’t involved in the study, said by email.
“Patient safety is the main concern so if we’re not getting that feedback, there’s no way for us to do anything positive to change our inventory or notify patients”, said Jim Stage, owner and pharmacist at Schneider Drug.
Over 10 years, almost 10% of all serious, or previously unlisted, adverse events, and more than 40,000 drug reactions resulting in the death of a patient, were not reported by drug manufacturers to the FDA within the 15-day requisite window, researchers reported. The team went on to state that patient death was associated with the delayed reporting.
Pinar Karaca-Mandic, Ph.D., the University of Minnesota School of Public Health, Minneapolis, and coauthors examined data from the FDA Adverse Event Reporting System for adverse event reports received from January 2004 through June 2014.
While the delays aren’t surprising, the focus on the 15-day time limit doesn’t account for the labor-intensive process manufacturers face in verifying adverse events before submitting reports to the FDA, said Kenneth Getz, a researcher at the Center for the Study of Drug Development at Tufts University School of Medicine.
Doctors also need to disclose known side effects to patients, a step that’s often skipped when patients are being recruited for trials, a separate study in the journal points out.
In a related Editor’s Note, Rita F. Redberg, M.D., M.South Carolina., editor of JAMA Internal Medicine, writes: “Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death….” “It does not say you are allowed more time if x, y or z; it’s just a flat-out 15-day reporting window because my interpretation is the FDA wants this information collected and reviewed as soon as possible”. “Physicians and their patients must be knowledgeable of benefits, harms and alternatives for a wide choice of treatments, especially those recently approved for which clinical experience is limited”.
In total, 1,613,079 AEs were included in the study.
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“Our findings are likely an underestimate of overall under-reporting or misreporting, given the anecdotal evidence of FDA warning letters to manufacturers alleging downward misclassification of serious AEs”.
