Important Drug Warning For Gadolinium-Based Contrast Agents Used for Magnetic Resonance Imaging

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September 12, 2007 – The U.S Food and Drug Administration (FDA), the equivalent to the Saudi Food and Drug Authority (SFDA)
, has requested manufacturers of all gadolinium-based contrast agents (GBCAs) to add a new Boxed Warning and new Warnings about Nephrogenic Systemic Fibrosis (NSF) to the full prescribing information for all gadolinium-based contrast agents (GBCAs) (Magnevist, MultiHance, Omniscan, OptiMARK, ProHance)
used in Magnetic Resonance Imaging (MRI).
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<p>This new labeling highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency (a glomerular filtration rate &lt;30 mL/min/1.73m2) and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs. </p>
<p>As of today, the FDA has received reports of over 250 cases of NSF after administration of gadolinium-based contrast agents.</p>
<p><strong>Recommendations and Considerations for Healthcare Professionals:</strong></p>
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<li>Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). </li>
<li>When administering a GBCA, do not exceed the dose recommended in product labeling. Allow sufficient time for elimination of the GBCA prior to any readministration.</li>
<li>Determine the renal function of patients by obtaining a medical history or conducting laboratory tests that measure renal function prior to using a GBCA. </li>
<li>For patients receiving hemodialysis, you may consider prompt hemodialysis following GBCA administration in order to enhance the contrast agent's elimination. However, it is unknown if hemodialysis prevents NSF. </li>
<li>The risk, if any, for developing NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown. </li></ul>
<p><strong>Report Adverse Drug Reactions to the Saudi FDA </strong></p>
<p>The public and health professionals are encouraged to report adverse drug reactions of Gadolinium-based contrast agent to the National Pharmacovigilance center on the internet at:</p>
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