Published Online: Monday, October 1, 2007

The FDA's drug-safety evaluation system is not working, according to Curt Furberg, MD, PhD, a medical epidemiologist at Wake Forest University (Winston-Salem, NC) and a former member of the FDA's drug safety and risk management advisory panel.

As coauthor of a study reported recently in the Archives of Internal Medicine, Dr. Furberg said that the FDA received 2 1/ 2 times more reports of serious health problems linked with medication in 2005, compared with 1998. The researchers noted that the reports of serious problems rose 4 times faster than the total number of US outpatient prescriptions. This type of medicine-related health problem was responsible for an estimated 3% to 6% of hospital admissions.

Reports of serious reactions not included on a label accounted for 87% of the increase from 1998 to 2005, noted the researchers. If physicians and patients were more apt to report problems, reports of adverse events mentioned on the label would have risen just as much, the investigators claimed.

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