Nephrogenic Systemic Fibrosis (NSF) with gadolinium-containing magnetic resonance imaging (MRI) contrast agents - Update

26 June 2007

The Commission on Human Medicines (CHM), together with the European Pharmacovigilance Working Party (PhVWP), is communicating updated advice on the risk of Nephrogenic Systemic Fibrosis (NSF) with the gadolinium-containing magnetic resonance imaging (MRI) contrast agents.

NSF, also known as nephrogenic fibrosing dermopathy (NFD), is a rare condition that involves fibrosis of the skin and connective tissues, which can lead to joint immobility and can affect other organs of the body sometimes leading to a fatal outcome. NSF has occurred only in patients with renal dysfunction; there are no known cases of NSF in patients with normal kidney function.

NSF was first associated with the gadolinium-containing MRI contrast agent Omniscan (gadodiamide) in 2006. In February 2007 the CHM together with the European PhVWP recommended that Omniscan should not be used in patients with severe kidney impairment and in patients who have had or are waiting liver transplantations. Further guidance was issued on our website:
› Nephrogenic Systemic Fibrosis (NSF) and gadolinium-containing MRI contrast agents - 7 February 2007

A review of new data suggests that Magnevist (gadopentetic acid) is also associated with an increased risk of NSF. The CHM, together with the PhVWP, recommends that Magnevist should also not be used in patients with severe kidney impairment. Further guidance is provided in the attached documents.

To date 180 worldwide cases of NSF have been reported with Omniscan and 78 cases of NSF with Magnevist.

The CHM and PhVWP are continuing to review this safety issue with the other gadolinium-containing MRI contrast agents and will communicate new information and prescribing advice as and when it becomes available.