Fatal adverse drug reactions: A worldwide perspective in the World Health Organization pharmacovigilance database
| Autor: | Jean-Louis Montastruc, Geneviève Durrieu, François Montastruc, Agnès Sommet, Haleh Bagheri, Claire de Canecaude, Margaux Lafaurie |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Drug Adolescent Databases Factual Drug-Related Side Effects and Adverse Reactions media_common.quotation_subject World Health Organization computer.software_genre 030226 pharmacology & pharmacy World health Immunomodulating Agents Pharmacovigilance 03 medical and health sciences 0302 clinical medicine medicine Adverse Drug Reaction Reporting Systems Humans Pharmacology (medical) 030212 general & internal medicine Drug reaction Retrospective Studies Lenalidomide media_common Pharmacology Database business.industry Odds ratio Confidence interval Thalidomide Pharmaceutical Preparations Female business computer medicine.drug |
| Zdroj: | British Journal of Clinical Pharmacology. 87:4334-4340 |
| ISSN: | 1365-2125 0306-5251 |
| Popis: | Aims Adverse drug reactions (ADRs) are important causes of death. However, the main involved drugs are relatively unknown. The present study was performed to characterise death-related drugs recorded in a large pharmacovigilance database during the last 10 years. Methods A retrospective analysis of VigiBase, the World Health Organization pharmacovigilance database, was performed investigating fatal ADRs registered between 1 January 2010 and 31 December 2019 in male and female patients aged ≥18 years and reported by physicians. Analyses were descriptive investigating age, sex and suspected drugs. Differences in reporting according to sex, age and continents were investigated using disproportionality analysis with calculation of reporting odds ratio and its 95% confidence interval. Results Among the 23 millions ADRs recorded in VigiBase, 3 250 967 were included with 43 685 fatal. They were reported mainly in patients older than 75 years. The 3 most frequently involved drug classes were antineoplastic/immunomodulating drugs followed by nervous system and cardiac drugs. The top 3 individual drugs were denosumab, lenalidomide and thalidomide with marked differences according to age, sex, continents and countries. The risk of reporting fatal ADRs was higher in males, in the Americas and in patients ≥65 years. Conclusion Fatal ADRs registered in a large pharmacovigilance database during the last 10 years correspond to just over 1% of the total number of ADRs. They occurred more in males, after 65 years and with antineoplastic/immunomodulating drugs in general. Our study also highlighted, for the first time, important differences in fatal ADRs between continents and countries. |
| Databáze: | OpenAIRE |
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