ADE number doubles in seven years

September 12, 2007

The number of adverse drug events reported to the FDA has doubled in the past seven years.

The number of serious adverse drug events occurring between 1998 and 2005 has more than doubled, according to a new report published in the Sept. 10 Archives of Internal Medicine. There were also twice as many ADE-related deaths reported during the same time period. The new information is based on the number of reports voluntarily submitted to the FDA through its Adverse Event Reporting System (AERS). A total of 467,809 serious events were associated with 1,489 drugs, but just 51 drugs were responsible for 43.6% of the reports and each had 500 or more reports associated with its use. The authors said the increase in ADE was four times faster than the growth in the total outpatient prescriptions in the U.S. during the same period and called the findings a serious public health problem.

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