| アブストラクト | BACKGROUND: Diclofenac, a nonsteroidal anti-inflammatory drug, is not a documented cause of rhabdomyolysis in the Summaries of Product Characteristics held by major regulators. There are, however, eight published single case reports that associate rhabdomyolysis with diclofenac. OBJECTIVE: Triggered by a serious local case report, this study was conducted to evaluate the evidence for a causal association between diclofenac and rhabdomyolysis. PATIENTS AND METHODS: A descriptive analysis of rhabdomyolysis associated with diclofenac was conducted by mining data from the WHO Global Database of Individual Case Safety Reports, VigiBase, and published case reports. RESULTS: 70 eligible cases were retrieved from VigiBase. The median age was 56.5 years (range 1-90). Where reported precisely (26 reports), the median time to onset of rhabdomyolysis following administration of diclofenac was 3 days. In 20 cases, diclofenac was reported as a sole suspect and was solely administered in 14 of these. In 30 cases, rhabdomyolysis abated following withdrawal of diclofenac. Seven of these cases fulfilled the WHO-UMC case-causality assessment criteria for 'probable'. Diclofenac was probably an indirect cause in another five reports where rhabdomyolysis ensued from injection-site necrosis. There were eight fatalities and intramuscular administration was over-represented in this group. In 27 patients taking lipid-lowering agents, the incidence of acute kidney injury with rhabdomyolysis was 62.9% compared with 37.1% for the whole cohort. Off-label use of diclofenac for minor or undiagnosed conditions was reported. CONCLUSION: Currently available data suggests a causal link between diclofenac and rhabdomyolysis either directly or indirectly. |
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| ジャーナル名 | Drugs - real world outcomes |
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| 投稿日 | 2021/4/1 |
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| 投稿者 | Russom, Mulugeta; Fitsum, Yodit; Abraham, Abiel; Savage, Ruth L |
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| 組織名 | Eritrean Pharmacovigilance Centre, National Medicines and Food Administration,;Ministry of Health, Asmara, Eritrea. satiswt@gmail.com.;Ministry of Health, Asmara, Eritrea.;Akordat Hospital, Ministry of Health, Akordat, Eritrea.;Uppsala Monitoring Centre, Uppsala, Sweden.;Division of Health Sciences, New Zealand Pharmacovigilance Centre, University of;Otago, Dunedin, New Zealand.;Department of General Practice, University of Otago, Christchurch, New Zealand. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33786776/ |
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