If someone takes a drug and experiences a side effect noted on its label, it’s time to discuss it with the prescribing doctor. But any side effect not noted on the label, and any serious adverse drug event, such as one requiring hospital admission, according to regulations, must be reported by the drug’s manufacturer to the FDA as soon as possible, but never later than 15 calendar days after it received the information.
Too often, that doesn’t happen.
According to research published in the JAMA Internal Medicine, over a 10-year period (2004 to 2014), nearly 1 in 10 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 window after receiving them from a doctor or patient.
In an editorial accompanying the research, Dr. Rita F. Redberg wrote, “Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death. However, no disciplinary actions have been taken when companies fail to submit reports to the FDA in the time frame required. Clearly, the lack of consequences contributes to a lack of deterrence for these illegal and dangerous delays.”
All drugs can be dangerous, whether purchased over the counter or with a prescription, and pharmaceutical companies have a poor record of copping to their products’ problems. And the FDA’s ability and/or willingness to track the safety of drugs have been criticized as weak.
The study looked at more than 1.6 million adverse event reports in the FDA’s tracking system. About 9 in 10 were reported in timely fashion, but the rest languished as long as 180 days before being submitted. As explained on MedPageToday.com, the delayed reports were more likely to involve a patient death than adverse events reported during the required window.
Some people support physicians reporting these events directly to the FDA, bypassing the manufacturer. The researchers and Redberg supported that idea, and Redberg also said the FDA could beef up enforcement with quick action to suspend drug sales or withdraw their approval.
“This would address the delay problem, although additional efforts to make the data available and take appropriate actions are still necessary,” Redberg wrote. “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.”
The researchers reviewed quarterly data from the FDA, and found that only about 5 in 100 adverse drug events were reported by patients. The team eliminated those from its analysis in order to focus on the actions of drug manufacturers.
After crunching all the numbers and learning that the more dire the adverse event, the longer it took drug manufacturers to report it, the researchers were led to believe that their findings probably underestimated the companies’ underreporting or misreporting.
