Warnings of fibrosis added to gadolinium-based contrast agents PI

October 4, 2007

A black box warning for nephrogenic systemic fibrosis has been added to the prescribing information of gadolinium-based contrast agents.

Postmarketing reports of nephrogenic systemic fibrosis (NSF) following administration of gadolinium-based contrast agents have led manufacturers of five gadolinium-based contrast agents to issue a Dear Healthcare Professional letter. The prescribing information for each product will now contain a black box warning and an updated Warnings section describing the risk for developing NSF. The agents increase the risk of NSF in patients with acute or chronic renal insufficiency (glomerular filtration rate 2) and patients with renal dysfunction due to hepatorenal syndrome or in the perioperative liver transplantation period. In NSF, excessive amounts of connective tissue form on internal organs and the skin. The condition is progressive and can be fatal. According to the letter, the FDA has received reports of more than 250 cases of NSF. The affected products include gadopentetate dimeglumine (Magnevist, Bayer), gadobenate dimeglumine (MultiHance, Bracco), gadodiamide (Omniscan, GE Healthcare), gadoversetamide (OptiMARK, Mallinckrodt), and gadoteridol (ProHance, Bracco). Gadolinium-based contrast agents are used during magnetic resonance imaging (MRI).

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