Reports to the Food and Drug Administration of adverse drug events increased by 25% in 2008 compared with 2007, according to a new
QuarterWatch report from the Institute for Safe Medication Practices, a Philadelphia-based not-for-profit dedicated to the prevention of medical errors.
The increase was the largest over a one-year period since the FDA began collecting data in 1998. According to researchers, the FDA received reports of nearly 100,800 cases of serious injury related to drug use in 2008 compared with 80,600 in 2007. Those numbers included a 56% increase in patient deaths—from 9,700 in 2007 to 15,200 in 2008.
The ISMP credited the surge in reported events to both the FDA's efforts to better identify adverse drug events and a slew of recalls on generic drugs such as heparin vials, and morphine and digoxin tablets during 2008. Last year, the agency increased the number of internet links through which physician could access its MedWatch site for reporting adverse events.
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