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 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. “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also tried to eliminate ‘noise’ in the reporting system, by excluding reports from more than 14 days after a drug was withdrawn.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.”
MEDICA.de; Source: Wake Forest University