Drugmakers Failed To Report Within 15 Days Serious Side Effects 10% of the Time, Study Finds
Drugmakers fail in about 10% of cases to meet a mandated time limit for disclosing serious side effects for their products, according to a study published in JAMA Internal Medicine. The study found about 160,000 reports of serious adverse events that were not disclosed by drugmakers within the required 15 days. Of those, about 40,500 reports involved patient deaths. About 88% of serious cases involving patient deaths were reported within 15 days, compared with about 91% of serious cases where a patient did not die.
- "Some Serious Drug Side Effects Not Told to FDA Within 15 Days" (Rapaport, Reuters, 7/27).