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September 14, 2005

The RADAR Project and the FDA—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;294(10):1206-1207. doi:10.1001/jama.294.10.1206-b

In Reply: The FDA is the primary source of adverse event data and reports. As noted by Dr Trontell, the evaluation of suspect adverse events by the recently initiated RADAR project and the FDA differ. Key distinctions are the RADAR project’s greater frequency of interactions with clinicians; a primary focus on potentially fatal ADRs; and different approaches to analysis, interpretation, causality assessments, and information dissemination.

Two cases illustrate these differences. The FDA identified high rates of pure red cell aplasia with use of the epoetin alfa formulation Eprex, during the years 1998 to 2001.1 RADAR expanded on these findings and reported that the increase occurred with subcutaneous administration of the human-serum-albumin–free formulation of Eprex primarily to chronic kidney disease patients in England, France, Canada, and Spain.2 In a second example, the FDA issued a “Dear Doctor” letter identifying 50 hypersensitivity cases associated with drug-eluting coronary artery stents and retracted an assertion of causality 1 month later.3 RADAR review of the FDA database identified 262 instances of hypersensitivity possibly caused or certain to be caused by drug-eluting coronary artery stents, 4 of which resulted in patient death.4

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