Diclofenac and the Risk of Rhabdomyolysis: Analysis of Publications and the WHO Global Pharmacovigilance Database
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 b...
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description | 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. |
doi_str_mv | 10.1007/s40801-021-00240-z |
format | Article |
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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.</description><identifier>ISSN: 2199-1154</identifier><identifier>EISSN: 2198-9788</identifier><identifier>DOI: 10.1007/s40801-021-00240-z</identifier><identifier>PMID: 33786776</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Arthritis ; Case reports ; Causality ; Data mining ; FDA approval ; Health risks ; Information retrieval ; Internal Medicine ; Kidneys ; Kinases ; Medicine ; Medicine & Public Health ; Nonsteroidal anti-inflammatory drugs ; Original ; Original Research Article ; Patients ; Pharmacology/Toxicology ; Pharmacotherapy ; Pharmacovigilance ; Rhabdomyolysis ; Side effects ; Statins ; Uric acid ; Urine</subject><ispartof>Drugs - real world outcomes, 2021-09, Vol.8 (3), p.263-275</ispartof><rights>The Author(s) 2021</rights><rights>The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c541t-db8f509bffc3351e877741a43cf09499653a9e7cb1fd69113dda4210b4f2ecdc3</citedby><cites>FETCH-LOGICAL-c541t-db8f509bffc3351e877741a43cf09499653a9e7cb1fd69113dda4210b4f2ecdc3</cites><orcidid>0000-0003-1939-5842 ; 0000-0003-1008-1679 ; 0000-0002-8932-0849 ; 0000-0001-8516-3113</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324666/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324666/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,41120,42189,51576,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33786776$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Russom, Mulugeta</creatorcontrib><creatorcontrib>Fitsum, Yodit</creatorcontrib><creatorcontrib>Abraham, Abiel</creatorcontrib><creatorcontrib>Savage, Ruth L.</creatorcontrib><title>Diclofenac and the Risk of Rhabdomyolysis: Analysis of Publications and the WHO Global Pharmacovigilance Database</title><title>Drugs - real world outcomes</title><addtitle>Drugs - Real World Outcomes</addtitle><addtitle>Drugs Real World Outcomes</addtitle><description>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.</description><subject>Arthritis</subject><subject>Case reports</subject><subject>Causality</subject><subject>Data mining</subject><subject>FDA approval</subject><subject>Health risks</subject><subject>Information retrieval</subject><subject>Internal Medicine</subject><subject>Kidneys</subject><subject>Kinases</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Nonsteroidal anti-inflammatory drugs</subject><subject>Original</subject><subject>Original Research Article</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Pharmacovigilance</subject><subject>Rhabdomyolysis</subject><subject>Side effects</subject><subject>Statins</subject><subject>Uric acid</subject><subject>Urine</subject><issn>2199-1154</issn><issn>2198-9788</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp9Ud9LHDEQDqWiov4DPpRAn9cmm-wm6UNBPOsVBEUqPoZJNrlLu7fRZE84__rm7uxVX_owzMD3Y4b5EDql5IwSIr5kTiShFalLkZqT6uUDOqypkpUSUn7czKqitOEH6CTnYAjngnHJxT46YEzIVoj2ED1Ngu2jdwNYDEOHx7nDdyH_xtHjuzmYLi5WsV_lkL_i8wE20xq7XZo-WBhDHPJO-DC9wVd9NNDj2zmkBdj4HGahh8E6PIERDGR3jPY89NmdvPYjdP_98ufFtLq-ufpxcX5d2YbTseqM9A1RxnvLWEOdFEJwCpxZTxRXqm0YKCesob5rFaWs64DXlBjua2c7y47Qt63v49IsXGfdMCbo9WMKC0grHSHo98gQ5noWn7VkNW_bthh8fjVI8Wnp8qh_xWUqP8i6bgVpKCsHFVa9ZdkUc07O7zZQotdJ6W1SuiSlN0nplyL69Pa2neRvLoXAtoRcoGHm0r_d_7H9Azn2oTA</recordid><startdate>20210901</startdate><enddate>20210901</enddate><creator>Russom, Mulugeta</creator><creator>Fitsum, Yodit</creator><creator>Abraham, Abiel</creator><creator>Savage, Ruth L.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88C</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>K60</scope><scope>K6~</scope><scope>K9.</scope><scope>KB0</scope><scope>L.-</scope><scope>M0C</scope><scope>M0S</scope><scope>M0T</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-1939-5842</orcidid><orcidid>https://orcid.org/0000-0003-1008-1679</orcidid><orcidid>https://orcid.org/0000-0002-8932-0849</orcidid><orcidid>https://orcid.org/0000-0001-8516-3113</orcidid></search><sort><creationdate>20210901</creationdate><title>Diclofenac and the Risk of Rhabdomyolysis: Analysis of Publications and the WHO Global Pharmacovigilance Database</title><author>Russom, Mulugeta ; Fitsum, Yodit ; Abraham, Abiel ; Savage, Ruth L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c541t-db8f509bffc3351e877741a43cf09499653a9e7cb1fd69113dda4210b4f2ecdc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Arthritis</topic><topic>Case reports</topic><topic>Causality</topic><topic>Data mining</topic><topic>FDA approval</topic><topic>Health risks</topic><topic>Information retrieval</topic><topic>Internal Medicine</topic><topic>Kidneys</topic><topic>Kinases</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Nonsteroidal anti-inflammatory drugs</topic><topic>Original</topic><topic>Original Research Article</topic><topic>Patients</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Pharmacovigilance</topic><topic>Rhabdomyolysis</topic><topic>Side effects</topic><topic>Statins</topic><topic>Uric acid</topic><topic>Urine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Russom, Mulugeta</creatorcontrib><creatorcontrib>Fitsum, Yodit</creatorcontrib><creatorcontrib>Abraham, Abiel</creatorcontrib><creatorcontrib>Savage, Ruth L.</creatorcontrib><collection>SpringerOpen(OpenAccess)</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>ABI/INFORM Collection</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>ProQuest - Health & Medical Complete保健、医学与药学数据库</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>ABI/INFORM Global (Corporate)</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>ABI/INFORM Global</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Health Management Database (Proquest)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content (ProQuest)</collection><collection>ProQuest One Business</collection><collection>ProQuest One Business (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Drugs - real world outcomes</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Russom, Mulugeta</au><au>Fitsum, Yodit</au><au>Abraham, Abiel</au><au>Savage, Ruth L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Diclofenac and the Risk of Rhabdomyolysis: Analysis of Publications and the WHO Global Pharmacovigilance Database</atitle><jtitle>Drugs - real world outcomes</jtitle><stitle>Drugs - Real World Outcomes</stitle><addtitle>Drugs Real World Outcomes</addtitle><date>2021-09-01</date><risdate>2021</risdate><volume>8</volume><issue>3</issue><spage>263</spage><epage>275</epage><pages>263-275</pages><issn>2199-1154</issn><eissn>2198-9788</eissn><abstract>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.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>33786776</pmid><doi>10.1007/s40801-021-00240-z</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0003-1939-5842</orcidid><orcidid>https://orcid.org/0000-0003-1008-1679</orcidid><orcidid>https://orcid.org/0000-0002-8932-0849</orcidid><orcidid>https://orcid.org/0000-0001-8516-3113</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Arthritis Case reports Causality Data mining FDA approval Health risks Information retrieval Internal Medicine Kidneys Kinases Medicine Medicine & Public Health Nonsteroidal anti-inflammatory drugs Original Original Research Article Patients Pharmacology/Toxicology Pharmacotherapy Pharmacovigilance Rhabdomyolysis Side effects Statins Uric acid Urine |
title | Diclofenac and the Risk of Rhabdomyolysis: Analysis of Publications and the WHO Global Pharmacovigilance Database |
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