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gadolinium-based contrast agents
Magnevist
  Pharmaceutical company:
Bayer, Bracco, GE, Mallinckrodt
www.fda.gov/cder/drug/infopage/gcca

NEW WARNING
Bayer Health, Bracco, GE Health, and Mallinckrodt have sent a "Dear Healthcare Professional" letter to bring attention to important new safety information regarding gadolinium-based contrast agents used in MRIs. The trade names of these drugs include Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. Post-marketing studies have shown an increased risk for the development of Nephrogenic Systemic Fibrosis (NSF) when this contrast medium is used in patients with acute or chronic severe renal insufficiency, in patients with renal impairment caused by hepatorenal syndrome, or in the perioperative liver transplantation period. The prescribing information for this drug now contains a black box warning outlining this problem and stating that all patients should be screened for renal function before use, that the recommended dose not be exceeded, and that an appropriate period of time be allowed to elapse for elimination of the drug from the body before readministering it for further MRI testing. Magnevist, MultiHance, Omniscan, OptiMARK, ProHance

     
   

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