The European Pharmacovigilance Working Party has recommended that Magnevist (from Bayer Schering) be contraindicated in patients with severe or end-stage renal impairment to help prevent a life-threatening skin disease linked to gadolinium-enhanced MRI, according to industry and U.K. regulatory sources.
The European Pharmacovigilance Working Party has recommended that Magnevist (from Bayer Schering) be contraindicated in patients with severe or end-stage renal impairment to help prevent a life-threatening skin disease linked to gadolinium-enhanced MRI, according to industry and U.K. regulatory sources.Magnevist joins GE's agent Omniscan, which was contraindicated in February in European patients at risk for nephrogenic systemic fibrosis.Bayer Schering has confirmed to Diagnostic Imaging that a new Magnevist product label with the contraindication will be submitted to all health authorities of all member states of the European Union. Bayer Schering said it is informing customers in close cooperation with the European health authorities. The Pharmacovigilance Working Party is part of the European Medicines Agency (EMEA), which is responsible for oversight of pharmaceuticals.Diagnostic Imaging reported erroneously on July 6 that the EMEA itself had significantly revised guidance for prevention of NSF. In fact, the EMEA directly influences use of only agents that are centrally authorized for European countries. Of the gadolinium agents available in Europe, only Vasovist is centrally authorized by the EMEA. The EMEA indirectly and strongly influences use of agents through its Pharmacovigilance Working Party."While it is true that the Pharmacovigilance Working Party conclusions are not legally binding, there is nevertheless an informal coordination mechanism in place providing for implementation of the conclusions across the EU," said EMEA press officer Monika Benstetter. "I believe that, overall, the Working Party conclusions have now been implemented. But the EMEA can speak only for Vasovist. For final confirmation on all the other products, you have to turn to the national competent authorities."The U.K.'s Medicines and Healthcare Products Regulatory Agency published the new guidance based on the Pharmacovigilance Party recommendations on its website on June 26.
According to the MHRA documents, both Magnevist and Omniscan are now contraindicated for the following cases:
Omniscan is also contraindicated for patients who have had a liver transplant or are awaiting liver transplantation.
Both agents should be used with caution in patients with moderate renal impairment (GRF or eGFR from 30 to 59 mL/min).Furthermore, all patients should be screened for renal dysfunction prior to gadolinium-enhanced MRI, through questions about history of disease and/or lab tests. Providers are urged to be cautious with all gadolinium agents in patients with severe kidney disease.The new guidance softens the committee's previous stance on hemodialysis as a means of clearing the body of gadolinium after a contrast-enhanced study. It has advised that hemodialysis "may useful in patients already on hemodialysis," whereas previously hemodialysis was not recommended. Nevertheless, the new guidance indicates there is no evidence that hemodialysis can prevent or treat development of NSF. The new stance on hemodialysis brings the European guidance closer to MR safe practice guidelines from the American College of Radiology that recommend immediate dialysis for patients already on hemodialysis.The FDA appears to have taken a more conservative approach for the whole class of gadolinium agents. On May 23, manufacturers were asked to put a black box warning indicating NSF risks for patients with severe kidney disease on all gadolinium agents: Magnevist, ProHance, Omniscan, OptiMark and MultiHance.For more from the Diagnostic Imaging archives:
FDA requests 'black box' warning on gadolinium contrast packaging
Deadly disease shadows MRI contrast exams
New ACR guidelines warn against Omniscan MR contrast use in patients with any kidney disease
European authorities warn against use of Omniscan in at-risk patients