Companies fail to report roughly one in 10 serious and unexpected medication side effects to the U.S. Food and Drug Administration (FDA) within a 15-day window specified by federal regulations to protect patient safety, a study finds.
Drug manufacturers are also less likely to disclose serious adverse events within this window when patient deaths are involved than when complications aren’t fatal, according to an analysis of 1.6 million side effect reports to the FDA from 2004 to 2014.
“Timely reporting of adverse drug events is critical for ensuring patient safety,” said senior study author Pinar Karaca-Mandic, a researcher at the University of Minnesota School of Public Health in Minneapolis.
“Ours is the first study to empirically examine the extent of delays in reporting,” she told Reuters Health by email.
Under U.S. regulations, when drug manufacturers become aware of serious complications linked to patient deaths, hospitalizations, disabilities, birth defects or previously unknown side effects, they are supposed to disclose these issues to the FDA more quickly than they would for minor problems or complications already described on medication labels, the researchers note in JAMA Internal Medicine.
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