The European Medicines Agency has warned providers not to use gadodiamide (Omniscan) in patients with poor renal function, due to the risk of nephrogenic systemic fibrosis, a rare and life-threatening skin disease.
The European Medicines Agency has warned providers not to use gadodiamide (Omniscan) in patients with poor renal function, due to the risk of nephrogenic systemic fibrosis, a rare and life-threatening skin disease.
A 49 year-old man with terminal renal failure (GFR 10 mL/min) was first exposed to gadodiamide (0.3 mmol/kg) during an MRA study in April 2003. He developed progressive NSF with severe skin changes and cachexia. He had additional gadodiamide-enhanced scans after April 2003, resulting in a lifetime cumulative dose of 0.6 mmol/kg. He died 30 months after his first exposure. (Image courtesy of Dr. Peter Marckmann, department of nephrology at Copenhagen University Hospital in Herlev, Denmark)
Nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy, may occur in patients with moderate to end-stage kidney disease after an MRI or MR angiography study with gadolinium-based contrast media. NSF causes problems in the joints and in some cases quickly results in loss of mobility or death.
In a decision released Feb. 7, the EMEA, the regulatory equivalent of the FDA for pharmaceutical product oversight for the European Union, advised that the agent should not be used in the following cases:
The agency also advised caution regarding the use of gadodiamide in neonates and infants up to one year old. Caution was again advised for all gadolinium-based agents administered to patients with severe renal impairment.
Cases of NSF were first reported in Europe in early 2006. The EMEA now says there have been 200 cases worldwide. In an article to appear in the March 2007 issue of Radiology, Dr. Phillip H. Kuo, an assistant clinical professor of radiology at Yale University, estimated the worldwide total at 400. As of Dec. 21, 2006, the FDA had received 90 U.S. case reports of NSF in patients who were administered a gadolinium-based MR contrast medium.
Currently, there are five FDA-approved gadolinium-based contrast agents: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. These agents are approved for use during an MR scan but not for use with MRA, despite widespread off-label use.
Most cases of NSF have been linked to Omniscan and OptiMARK, which is sold in the U.S. but not approved in Europe, according to the EMEA. Most U.S. cases reported to the FDA were linked to Omniscan administration, according to the FDA Web site. A few cases have been associated with Magnevist at high doses, the EMEA reported.
Unlike the European agency, the FDA has taken a broader stance on the issue, advising caution for all gadolinium agents in high-risk patients. Kuo questioned that position in his pending March editorial. He concluded that Omniscan should not be used in patients with any level of renal disease.
NSF is very rare, and most cases are related to the specific agent Omniscan. Issuing a warning for all agents could unnecessarily deprive millions of patients access to gadolinium contrast, according to Kuo.
For more information from the Diagnostic Imaging archives:
FDA renews warning on gadolinium in patients with weak kidneys
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.
New Literature Review Assesses Merits of Cardiac MRI After Survival of Sudden Cardiac Arrest
April 19th 2024While noting inconsistencies with the diagnostic yield of cardiac MRI in patients who survived sudden cardiac arrest, researchers cited unique advantages in characterizing ischemic cardiomyopathy (ICM) and facilitating alternate diagnoses.
Study of Ofatumumab for Multiple Sclerosis Shows 'Profoundly Suppressed MRI Lesion Activity'
April 17th 2024The use of continuous ofatumumab in patients within three years of a relapsing multiple sclerosis diagnosis led to substantial reductions in associated lesions on brain MRI scans, according to research recently presented at the American Academy of Neurology (AAN) conference.
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.
New Literature Review Assesses Merits of Cardiac MRI After Survival of Sudden Cardiac Arrest
April 19th 2024While noting inconsistencies with the diagnostic yield of cardiac MRI in patients who survived sudden cardiac arrest, researchers cited unique advantages in characterizing ischemic cardiomyopathy (ICM) and facilitating alternate diagnoses.
Study of Ofatumumab for Multiple Sclerosis Shows 'Profoundly Suppressed MRI Lesion Activity'
April 17th 2024The use of continuous ofatumumab in patients within three years of a relapsing multiple sclerosis diagnosis led to substantial reductions in associated lesions on brain MRI scans, according to research recently presented at the American Academy of Neurology (AAN) conference.
2 Commerce Drive
Cranbury, NJ 08512