Application for Inclusion of Gadolinium-Based Contrast Agents to the WHO
Application for inclusion of Gadolinium‐based contrast agents to the WHO Essential List of Medicines Submitted by Daniel Patiño, PhD (McMaster) Faculty of Medicine University of Antioquia, Medellin, Colombia Holger J. Schünemann, MD, PhD Chair and Professor, Departments of Clinical Epidemiology and Biostatistics Co‐Director, WHO Collaborating Center for Evidence Informed Policy, McMaster University Potential conflicts of interest Dr. Patiño and Dr. Schünemann declare that they have no COI. Date: Dec 15, 2014 1 Application to add Gadolinium‐based contrast agents to the WHO Essential List of Medicines 1. Summary statement of the proposal for inclusion, change or deletion Currently the 18th edition of WHO Model List of Essential Medicines does not include gadolinium‐based contrast agents (Gd‐CAs) under 14.2 radio contrast media classification. Since the introduction of gadopentate dimeglumine in 1988, gadolinium‐based contrast agents have significantly improved the diagnostic efficacy of Magnetic Resonance Image (MRI) (1). Gadolinium‐based contrast agents are intravenous agents used for contrast enhancement with magnetic resonance imaging (MRI) and with magnetic resonance angiography (MRA). The Gd‐CAs are available for different types of MR scan varying from product to product, including liver, brain and whole body scan. This application proposes to add Gd‐CAs for the complementary list of WHO Essential List of Medicines to be used in the detection of lymph node metastases. It will focus on the following ‘general purpose’ Gd‐CAs: gaodopentate dimeglumine, gadodiamide, gadoversetamide, gadobenate dimeglumine, gadoteridol, gadoteric acid, gadobutrol. We will not include the ‘newer’ Gd‐CAs that are organ specific like the hepatobiliary‐specific contrast agents that are available for imaging the liver (e.g., gadoxetic acid).
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