Ablavar gadofosveset regulatory update

FDA said it will contraindicate 3 gadolinium-based MRI contrast agents in patients with acute kidney injury or chronic severe kidney disease: Magnevist gadopentetate dimeglumine, Omniscan gadodiamide and Optimark gadoversetamide. The move comes after the agency's safety review associated the drugs with a greater risk of nephrogenic systemic fibrosis (NSF) compared to other agents in patients with kidney disease. FDA will also require updated labels for gadolinium-based contrast agents to warn about the risk of NSF in patients with kidney disease and recommend screening patients to detect the kidney dysfunction before use of the drugs. Last year, an FDA panel discussed the risk of NSF associated with use of the contrasts agents in patients with renal impairment, but did not come to a consensus on whether the agents should be specifically contraindicated in the population. The panel noted that a black box warning in place since 2007 had already changed prescribing practices enough to significantly reduce new cases of NSF (see BioCentury, Dec. 14, 2009). ...