Omniscan® (a gadolinium-containing contrast medium, GE Healthcare) is a nonionic contrast medium licensed by HSA in 1996 for body, cranial and spinal magnetic resonance imaging (MRI). It provides contrast enhancement and facilitates visualisation of abnormal structures or lesions in various parts of the body including the central nervous system. Gadolinium-containing agents were first approved for clinical MRI use in 1988.
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Post-marketing reports of NFD/NSF
Over a 4-year period up to Apr 2006, GE Healthcare has received 25 case reports of serious and unexpected reactions of nephrogenic fibrosing dermopathy (NFD) and nephrogenic systemic fibrosis (NSF) in association with the use of Omniscan®. Twenty of these were reported in Denmark and five in Austria.1
Patients with NSF/NFD experience swelling and tightening of the skin, usually limited to the extremities. These conditions may develop over a period of days to several weeks. For most cases, the skin thickenings (as a result of fibrosis) inhibit the flexion and extension of joints, resulting in contractures.2 In rare incidences, a rapid and fulminant disease course may occur and result in death by restricting effective ventilation, or by restricting mobility to the point of causing falls.
All patients who developed NSF/NFD had severely impaired renal function, with the majority receiving dialysis before Omniscan® was administered. The dose of Omniscan® given to the patients was within the standard dose range used for MR angiography. The onset of NSF/NFD from the time of administration of Omniscan® ranged from six days to three months. The demographics of the patients involved are listed in Table 1 below.
Table 1
Mean age of patients | 52.5 ± 10.8 years old |
Number of male patients | 11 |
Number of female patients | 14 |
Number of patients on dialysis* | 20 |
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Conclusion
Healthcare professionals are reminded that the package insert of Omniscan® carries a special warning for its use in patients with severely impaired renal function (GFR <10ml/min) and that care should be exercised before using Omniscan® in such patients. Other gadolinium-containing contrast agents registered in Singapore includes OptiMARK®, Magnevist® and MultiHance®. Healthcare professionals are encouraged to report any serious adverse reaction arising from these products to the Pharmacovigilance Unit of the HSA.
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References
- Nephrol Dial Transplant 2006; 21:1104-1108.
- The International Center for Nephrogenic Fibrosing Dermopathy Research (ICNFDR) http://www.icnfdr.org
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