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Drug Induced Liver Injury: Perspective of the Adverse Drug Reaction Reports to the Portuguese Pharmacovigilance System from 2010 to 2019

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Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal
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CICS-UBI-Health Sciences Research Centre, Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal
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UFBI—Pharmacovigilance Unit of Beira Interior, Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal
*
Author to whom correspondence should be addressed.
Academic Editor: Pedram Sendi
Healthcare 2021, 9(12), 1630; https://doi.org/10.3390/healthcare9121630
Received: 29 October 2021 / Revised: 19 November 2021 / Accepted: 23 November 2021 / Published: 25 November 2021
(This article belongs to the Section Medication Management)
Background: Drug induced liver injury (DILI) is an adverse drug reaction that causes liver damage in a predictable (dose-dependent) or an unpredictable (idiosyncratic) fashion. We performed an assessment of DILI in Portugal, by analyzing the reports, sent to the Portuguese Pharmacovigilance System (PPS). Methods: A search was performed on the PPS database, in a 10-year time frame, from 1 January 2010 to 31 December 2019. Results: There was not a prevalence of either sex in any age group. Most reports (n = 1120, 55.0%) belonged to patients in the age group 19–64 years old. Hepatitis (n = 626, 26.7%) was the most common adverse drug reaction in our study. Hepatotoxicity (n = 362, 15.5%) and hepatitis (n = 333, 14.2%) were more frequent in age group 19–64 years old. Cholestasis was more prevalent in adults independently of age. Hepatic fibrosis and encephalopathy were more common in the elderly. Most patients consumed between one and four suspected drugs (n = 1867, 92%). Most patients in our study evolved to “cure” (n = 796; 39%). Hepatotoxicity (n = 23; 13.8%) and hepatitis (n = 610; 25.9%) had a female predominancy while choluria (n = 8; 4.8%) and splenomegaly (n = 8; 4.8%) were of male predominance. Conclusions: DILI is rare but can be fatal. As such, an active search of DILI is necessary. View Full-Text
Keywords: drug induced liver diseases; adverse drug reaction reporting systems; pharmacovigilance system; product surveillance; post-marketing drug induced liver diseases; adverse drug reaction reporting systems; pharmacovigilance system; product surveillance; post-marketing
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MDPI and ACS Style

Nunes, D.R.d.C.M.A.; Breton, M.C.; Monteiro, C.S.d.J.; dos Santos, J.L. Drug Induced Liver Injury: Perspective of the Adverse Drug Reaction Reports to the Portuguese Pharmacovigilance System from 2010 to 2019. Healthcare 2021, 9, 1630. https://doi.org/10.3390/healthcare9121630

AMA Style

Nunes DRdCMA, Breton MC, Monteiro CSdJ, dos Santos JL. Drug Induced Liver Injury: Perspective of the Adverse Drug Reaction Reports to the Portuguese Pharmacovigilance System from 2010 to 2019. Healthcare. 2021; 9(12):1630. https://doi.org/10.3390/healthcare9121630

Chicago/Turabian Style

Nunes, David R.d.C.M.A., Michèle C. Breton, Cristina S.d.J. Monteiro, and Jorge L. dos Santos. 2021. "Drug Induced Liver Injury: Perspective of the Adverse Drug Reaction Reports to the Portuguese Pharmacovigilance System from 2010 to 2019" Healthcare 9, no. 12: 1630. https://doi.org/10.3390/healthcare9121630

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