Causality assessment between reported fatal cerebral haemorrhage and suspected drugs: developing a new algorithm based on the analysis of the Japanese Adverse Event Report (JADER) database and literature review.
Purpose: Cerebral haemorrhage is a life-threatening event with various causes including adverse drug reactions (ADRs). Several methods have been proposed for the causality assessment of ADRs, but none specific for cerebral haemorrhage. The purpose of this study was to develop an algorithm for causal...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 77; no. 10; pp. 1443 - 1453 |
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| Autor principal: | |
| Formato: | algorithm research systematic review tables/charts Journal Article |
| Publicado: |
Springer Nature
Oct2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=152446991&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 152446991 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Oct2021 vid: 77 iid: 10 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 152446991 149684188 152446991 152446991 10.1007/s00228-021-03131-y 152446991 ppf: 1443 ppct: 10 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Causality assessment between reported fatal cerebral haemorrhage and suspected drugs: developing a new algorithm based on the analysis of the Japanese Adverse Event Report (JADER) database and literature review. aug: au: Ohta, Miki affil: Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia sug: subj: Algorithms Causal Attribution Evaluation Adverse Drug Event Cerebral Hemorrhage Mortality Cerebral Hemorrhage Chemically Induced Human Systematic Review Japan Descriptive Statistics Death ab: Purpose: Cerebral haemorrhage is a life-threatening event with various causes including adverse drug reactions (ADRs). Several methods have been proposed for the causality assessment of ADRs, but none specific for cerebral haemorrhage. The purpose of this study was to develop an algorithm for causality assessment between drugs and fatal cerebral haemorrhage, based on the analysis of data from the Japanese Adverse Drug Event Report (JADER) database and literature review. Methods: All fatal ADRs reported in the JADER database between April 2004 and March 2020 were searched, and literature on drug-related cerebral haemorrhage or general causality assessment was reviewed to summarise the information on causality between cerebral haemorrhage and ADRs. Results: Of the 50,095 cases identified in the JADER database, cerebral haemorrhage was the fifth most reported cause of fatal ADRs, but the causality of >80% of the events was published as 'Unassessable'. The literature review identified articles on drug-related cerebral haemorrhage and causality assessment methods in general. Based on these articles, information on five categories (temporal relationship, previous knowledge about the relationship between drug action and ADRs, alternative aetiological candidate, appropriateness of drug use, and the relationship between death and ADRs) was determined for causality assessment between a suspected drug and fatal cerebral haemorrhage; a new algorithm was created using this information. Conclusion: In this study, the information considered necessary for causality assessment between drugs and fatal cerebral haemorrhage was reviewed and an assessment algorithm was developed. Future studies are needed to validate the usefulness of this method. pubtype: Academic Journal doctype: algorithm research systematic review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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