Unexpected pegensatide failure: Plea for an extension of an effective FDA early warning system.

e17625 Background: Historically, a mean of 11 years elapses before a Black Box warning is added to product labels of FDA approved drugs. It is unusual for a recently approved drug to be withdrawn from the market for safety reasons within 1 year of FDA approval. More unusual is for FDA withdrawal to occur when an unexpected toxicity develops in a very small number of patients. We reported in the New England Journal of Medicine (Bennett CL et al, NEJM) that the largest dialysis organization in the US initiated a pilot introduction of peginesatide amongst chronic kidney disease patients in 10 dialysis centers. We now report a comparison of the quality, completeness, and timing of the 28 adverse event reports submitted to the FDA from the pilot introduction versus the 10 reports submitted to the FDA from centers that did not participate in the pilot introduction. Methods: The pilot introduction was conducted at 10 LDO centers, a nurse funded by the manufacturer of peginesatide was assigned to each center to f...