WASHINGTON — The number of serious drug side effects and deaths reported to the U.S. Food and Drug Administration more than doubled over an eight-year period, according to an analysis of adverse-drug events reported to the agency. As part of the agency’s so-called MedWatch reporting system, drug companies, health-care professionals and the public can file reports when they think a drug is connected to a side-effect or fatality. Drug companies are required to file such reports while they are voluntary for health-care professionals. A study, published in Monday’s Archives of Internal Medicine, looked at reports that are considered serious from 1998 to 2005. The study was conducted by researchers at the Institute for Safe Medication Practices in Huntingdon Valley, Pa., and Wake-Forest University School of Medicine in Winston-Salem, N.C. Such reports also included reports of deaths in which people believe a particular drug might have contributed to, or caused, the death. Adverse-event reports have to be investigated by the FDA as the reports themselves don’t necessarily mean a particular drug or drugs caused a problem. A serious adverse drug event, defined by the FDA, means an event that resulted in death, a birth defect, disability, hospitalization, […]
Tuesday, September 11th, 2007
Study Shows Steep Rise In Adverse Drug Reactions
Author: JENNIFER CORBETT DOOREN
Source: Wall Street Journal
Publication Date: September 10, 2007 5:28 p.m.
Link: Study Shows Steep Rise In Adverse Drug Reactions
Source: Wall Street Journal
Publication Date: September 10, 2007 5:28 p.m.
Link: Study Shows Steep Rise In Adverse Drug Reactions
Stephan: