Drug side effects not told to FDA within 15 days

Overall, 160,383 serious adverse events, or 10 percent of reports, were not disclosed by companies within 15 days – including nearly 40,500 reports involving patient deaths. 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. “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. Read more: Reuters

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