Safety of gadopentetate dimeglumine after 120 million administrations over 25 years of clinical use
| Autor: | Kohki Yoshikawa, Fumiki Shimada, Masahisa Yabuki, Petra Palkowitsch, Toru Matsumura, Susan Dohanish, Masakane Hayakawa |
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| Rok vydání: | 2013 |
| Předmět: |
Gadolinium DTPA
medicine.medical_specialty Internationality Contrast Media Nephrogenic Fibrosing Dermopathy Pharmacovigilance Drug Utilization Review Japan medicine media_common.cataloged_instance Humans Radiology Nuclear Medicine and imaging Longitudinal Studies Registries European union Adverse effect media_common business.industry Incidence (epidemiology) medicine.disease Magnetic Resonance Imaging United States Europe Reporting rate Nephrogenic systemic fibrosis Emergency medicine business Regional differences |
| Zdroj: | Magnetic resonance in medical sciences : MRMS : an official journal of Japan Society of Magnetic Resonance in Medicine. 12(4) |
| ISSN: | 1880-2206 |
| Popis: | Purpose We evaluated the safety of gadopentetate dimeglumine (Gd-DTPA), the first contrast agent for magnetic resonance imaging, using pharmacovigilance data for spontaneously reported adverse events (AEs) after 120 million cumulative administrations worldwide. Methods We analyzed spontaneously reported AEs for Gd-DTPA for pre-specified time periods between 1988 and 2011. Results Since the market introduction of Gd-DTPA in 1988, its global utilization reached 120 million cumulative administrations in 2011, more than 80% of which was by the USA, countries in the European Union (EU), and Japan. The global AE reporting rate was 21.2 in 100,000 administrations in 1988 and 14.4 in 100,000 administrations by 2011. Regional differences included higher reporting rates in the USA and Japan, and reporting rates lower than global rates in the EU. The reported rate of global serious AEs changed from 1.4 in 100,000 administrations in 1988 to 4.0 in 100,000 administrations in 2011. The highest number of reports of nephrogenic systemic fibrosis (NSF) was received from 2006 to 2008. Since 2009, no report of a current onset of NSF has been received. The reduced report rate of NSF may be due to increased awareness about the use of gadolinium-based contrast agents (GBCAs). Conclusion After more than 120 million cumulative administrations, Gd-DTPA is a widely used GBCA that shows a consistently low and stable incidence of AEs. |
| Databáze: | OpenAIRE |
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