October 2007

Adverse drug events reported to the FDA have soared

A new study shows the number of drug‑therapy related deaths and injuries reported to the U.S. Food and Drug Administration (FDA) nearly tripled between 1998 and 2005.

A researcher at Wake Forest University School of Medicine and colleagues reviewed serious and fatal drug events reported in that eight‑year period to the FDA by consumers, health professionals and drug manufacturers, and found that serious adverse drug events increased 2.6‑fold, from about 35,000 to nearly 89,000, and adverse drug‑related deaths increased 2.7‑fold, from about 5,500 to more than 15,000.

The study is reported in the Sept. 10 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

The FDA receives these reports of serious adverse drug events through its Adverse Event Reporting System. Better known to health professionals as "MedWatch," this system has been in operation under the same database system since 1998, with consistent regulatory requirements for drug manufacturers.

The study also reported serious events increased four times faster than the total number of outpatient prescriptions during that period.

"This marked increase of serious injuries from drug treatment is of great concern," said Curt Furberg, M.D., Ph.D., professor of public health sciences at Wake Forest University School of Medicine, and a co‑author of the report. "It shows current efforts to ensure the safety of drugs are not adequate, and that physicians and patients are unaware of these risks."

Furberg has previously called for far‑reaching changes in drug safety regulation, including expanded authority for the FDA, higher priority for drug safety and new systems to monitor drugs once they are approved by the FDA.

"The study found that a relatively small number of drugs accounted for the most reported serious adverse drug events," said Thomas J. Moore, A.B., of the Institute for Safe Medication Practices (ISMP), and the lead author.

The authors of this study took into account several factors that might influence their findings.

"We saw no evidence that doctors and patients had become more active in reporting events in some across‑the‑board fashion," said Furberg. "We also tried to eliminate 'noise' in the reporting system, by excluding reports from more than 14 days after a drug was withdrawn. In addition, we excluded events that were not serious, and foreign reports to focus on U.S. risks."