Back to Search
Start Over
Off‐Label Use of Hydroxychloroquine in COVID‐19: Analysis of Reports of Suspected Adverse Reactions From the Italian National Network of Pharmacovigilance
- Source :
- The Journal of Clinical Pharmacology. 62:646-655
- Publication Year :
- 2022
- Publisher :
- Wiley, 2022.
-
Abstract
- This study aimed to characterize adverse drug reactions (ADRs) to hydroxychloroquine in the setting of Covid-19, occurring in Italy in the period March-May 2020. The analysis of the combination therapy with azithromycin or/and lopinavir/ritonavir as well as a comparison with ADRs reported throughout 2019 was performed. ADRs collected by the Italian National Network of Pharmacovigilance were analysed for their incidence, seriousness, outcome, co-administered drugs, MedDRA classification. 306 reports were gathered for the quarter of 2020: 54 % non-serious and 46 % serious, and half of the latter required either the hospitalisation or its prolongation. However most of them were either completely recovered (26 %) or in the process of recovery (45 %), except for 9 fatal cases. Throughout 2019, 38 reports were collected, 53 % non-serious and 47 % serious, but no death had been reported. Diarrhea, prolonged QT interval and hypertransaminasemia were the most frequently ADRs reported in 2020, significantly higher than 2019 and specific for COVID-19 subjects treated with hydroxychloroquine. The logistic regression analyses demonstrated that the likelihood of serious ADR, QT prolongation and diarrhea significantly increased with hydroxychloroquine dosage. Co-administration of lopinavir/ritonavir and hydroxychloroquine showed a positive correlation with diarrhea and hypertransaminasemia and a negative relationship with the ADR seriousness. The combination therapy with azithromycin was another independent predictor of a serious ADR. Off-label use of hydroxychloroquine for COVID-19, alone or in combination regimens, was associated with increased incidence and/or seriousness of specific ADRs in patients with additional risk factors caused by the infection. This article is protected by copyright. All rights reserved.
- Subjects :
- Diarrhea
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions
MedDRA
Lopinavir/ritonavir
Azithromycin
QT interval
Lopinavir
Pharmacovigilance
Internal medicine
Humans
Medicine
Pharmacology (medical)
Pharmacology
adverse drug reactions
Ritonavir
business.industry
Incidence (epidemiology)
COVID-19
lopinavir/ritonavir
Hydroxychloroquine
Off-Label Use
COVID-19 Drug Treatment
azithromycin
hydroxychloroquine
Long QT Syndrome
business
medicine.drug
Subjects
Details
- ISSN :
- 15524604 and 00912700
- Volume :
- 62
- Database :
- OpenAIRE
- Journal :
- The Journal of Clinical Pharmacology
- Accession number :
- edsair.doi.dedup.....4b9cb060db69170c4a518b5f83dbcb78