May 4 2005
As many as hundreds of thousands of lives may have saved by a program that identifies serious, sometimes fatal medication reactions.
The program, the Research on Adverse Drug Events and Reports, or RADAR, has identified previously unreported problems associated with 15 common drugs, said lead researcher and program director Dr. Charles L. Bennett of Northwestern University.
RADAR, is sponsored by government grants and supplements the Food and Drug Administration 's (FDA) own monitoring system, and it compiles reports submitted to the FDA by drug companies and independent researchers.
Between 1998 and 2004, RADAR discovered 1,700 patients suffering serious reactions resulting in 170 deaths, from 14 drugs and drug-coated cardiac stents.
The U.S. Congress is considering legislation that would create an independent center within the FDA to monitor the safety of post-approval drugs. The center would have the ability to force drugmakers to conduct post-approval safety clinical trials and change label wordings to warn consumers about risks found after approval.
Bennett and colleagues reported their findings in the May 4 Journal of the American Medical Association.