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Report says side-effects 'RADAR' works

CHICAGO, May 3 (UPI) -- U.S. researchers said a program that identifies serious, sometimes fatal medication reactions may have saved hundreds of thousands of lives.

The Research on Adverse Drug Events and Reports, or RADAR, program has identified formerly unreported problems associated with 15 common drugs, said lead researcher and program director Dr. Charles L. Bennett of Northwestern University.

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Bennett and colleagues reported their findings in the May 4 Journal of the American Medical Association.

RADAR, sponsored by government grants, compiles reports submitted to the Food and Drug Administration by drug companies and independent researchers. The program supplements the FDA's own monitoring system.

Between 1998 and 2004, RADAR discovered 1,700 patients suffering serious reactions from 14 drugs and drug-coated cardiac stents, reactions that caused 170 deaths.

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.

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