Drug manufacturers are boxing patients in with delayed adverse event reporting

Drug manufacturers have delayed in reporting to the FDA nearly 10 percent of serious adverse events related to consumer medications, according to the results of a University of Minnesota researcher’s study, which was published in the American Medical Association’s JAMA Internal Medicine. Although drug companies are obligated to report unexpected adverse events and side effects resulting from their medications within 15 days, according to the study, manufacturers were regularly skirting that obligation and were less likely to meet the deadline when the adverse event led to a patient death. An additional study, in the same journal raised patient safety concerns over the lack of disclosure of boxed warnings to human subjects in medical research.


Pinar Karaca-Mandic, the author of the adverse event study called the research the “first to empirically examine the extent of delays in reporting.” The study analyzed serious adverse event reports received by the FDA between January 2004 and January 2014. Out of 1.6 million reports reviewed, researchers discovered that 160,383 of those reports were not received by the FDA within the 15-day reporting window. Out of those 160,383 late reports, 40,464 involved patient deaths. The serious adverse events that did not involve death were related to cases that were life-threatening, required hospitalization, resulted in disability, or led to birth defects. Researchers discovered that in addition to not meeting the 15-day reporting obligation, some manufacturers took considerably longer, with 3 percent of reports being reported within three to six months and an additional 3 percent taking six months or longer to report.


Rita Redberg, the editor of JAMA Internal Medicine told the Associated Press that “such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death.” Additionally, she recommended that physicians who report patient’s adverse reactions to drugs should report those adverse events directly to the FDA rather than to the manufacturer. Redberg also recommended that the FDA employ its ability to suspend drug sales or withdraw approval for unsafe medications in order to encourage timely reporting.

Boxed warnings

Another study, published in the same journal, focused on an additional threat to patient safety related to boxed warnings. The study analyzed the disclosure of boxed warnings to research patients. Roughly 35 percent of all FDA-approved drugs carry a boxed warning as part of a manufacturer’s full prescribing information. The boxed warning is usually related to potential toxic effects of the drug, when they are serious enough to be considered potentially fatal, life threatening, or permanently disabling. Researchers found that out of 57 consent forms, 63 percent did not disclose one or more boxed warning risks to patients considering participation in a research study.