Cardiac advisories from regulatory agencies differ between countries
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Cardiac advisories from regulatory agencies differ between countries Post-marketing cardiac safety advisories from regulatory authorities differ between Australia, Canada, the UK and USA, according to findings of a study published in Pharmacology Research and Perspectives. Recommendations including monitoring advice in all safety advisories on cardiac-related adverse events which were issued between 2010 and 2016 by the Therapeutic Goods Administration (TGA) in Australia, Health Canada (HC), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US FDA were compared. In total, 164 safety advisories on cardiac-related adverse events were released by the four regulatory authorities during the study period; 34.8% were by the MHRA, 24.4% by the FDA, 21.3% by the TGA and 19.5% by HC. The advisories involved 61 drugs, but only 14.7% of these drugs had advisories from all regulatory agencies in countries in which they were approved. The most frequently reported adverse events in cardiac advisories were arrhythmias (59%; including tachycardia, QT interval prolongation and heart arrest), coronary artery disorders (24%), heart disorders, signs or symptoms (12.8%) and health failure (10.4%). The most frequent types of advisories were alerts in Australia (54.3%), the UK (50.9%) and the US (75%), and direct health professional communications in Canada (68.8%). Overall, 58.4% of cardiac advisories were about 11 drugs: rosiglitazone (7.3%), dextropropoxyphene (6.1%), fingolimod (6.1%), domperidone (5.5%), denosumab (4.8%), dronedarone (4.3%), ondansetron (4.3%), citalopram (3.7%) and dabigatran (3.7%). Although the most frequent advice to healthcare professionals was to monitor patients (45%), only 41% of these advisories gave advice on monitoring. In a case study on citalopram and escitalopram, all regulators issued advisories on the risks of QT prolongation and torsades de pointes, but only the FDA and HC advised on the risk of death, and the agencies provided differing advice on monitoring. "There was a low level of concordance between regulators in the decision to warn clinicians, leading to potential differences in knowledge and care between patients in different countries. Monitoring information was also often inadequate. This is particularly concerning considering the potentially fatal nature of many cardiac adverse effects," concluded the authors. Hooimeyer A, et al. Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Pharmacology Research and Perspectives 8: No. 6, 9 Nov 2020. Available from: URL: https://doi.org/10.1002/prp2.680
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