FDA Adverse Drug Event Reports Jump in Past Decade

(USA.gov)

Researchers at University of Maryland School of Pharmacy in Baltimore found a sharp increase in reports of adverse drug events to the Food and Drug Administration in the years 2000 through 2009, but the reasons for the jump may be more complex than the quality of the drugs. Their findings appear in the March issue of the journal Archives of Internal Medicine (paid subscription required).

The FDA uses the Adverse Event Reporting System (AERS), according to its Web site, to monitor for new adverse events and medication errors of all approved drug and therapeutic biologic products. The site notes that “Reporting of adverse events from the point of care is voluntary in the United States,” and provided by professionals as well as consumers. Drug makers, however, are required by federal regulations to report possible health problems possibly linked to their products.

The Maryland team found in the years 2000 through 2009, 2.2 million events were reported to AERS, which represents a 1.65-fold increase over the previous decade. Maryland pharmacy professor and study leader Sheila Weiss Smith cautions, however, that the increasing number of reports may not reflect the actual number of adverse events linked to drugs.

Weiss Smith attributes the rise in adverse event reports to a number of factors. Safety warnings in recent years have contributed to an uptick of the adverse event reports, for example, she says.

Other possible factors include an aging population that takes more prescription drugs, more people are taking medications for multiple medical conditions, and more people overall taking multiple drugs for longer periods of time with the potential for harmful drug interactions.

Weiss Smith says the volume of the reports may hide more important issues with the quality of the data itself. For example, they found one-third of the events reported did not include the patient’s age. “Without ages,” says Weiss Smith, “you have to throw out those reports.”

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