Safety profile of hydroxychloroquine used off-label for the treatment of patients with COVID-19: A descriptive study based on EudraVigilance data.
Fundam Clin Pharmacol
; 36(6): 1099-1105, 2022 Dec.
Article
in English
| MEDLINE | ID: covidwho-1832057
ABSTRACT
At the beginning of the COVID-19 pandemic, worldwide attempts were made to identify potential drugs effective against the COVID-19. Hydroxychloroquine was among the first receiving attention. However, following its use in therapy, it has been shown that hydroxychloroquine was not only ineffective but probably, due to its known side effects, even responsible of increased mortality of patients. The objective of this study was to review the safety profile of hydroxychloroquine used off-label for the treatment of COVID-19. We analyze the reports of suspected adverse drug reactions (ADRs) collected in EudraVigilance, the European database of ADR reports. We collected 2266 reports for 2019 and 6525 for 2020. The most reported ADRs during 2020 were those relating to cardiac, hepatic, renal toxicity such as QT prolongation with 400 cases in 2020 (of which, 345 cases-9.97%-with COVID-19 as a therapeutic indication) versus 1 case only in 2019 (0.01%), long QT syndrome 38 cases in 2020 (36 as COVID-19 treatment) versus 0 in 2019, hepatitis 13 cases in 2019 (0.11%) and 132 in 2020, and 32 cases (24, 0.69%) of acute kidney injury in 2020 and only 3 cases in 2019. Moreover, some important vision-related ADRs also increased significantly during 2020, such as retinal toxicity with 92 cases in 2020 versus 7 in 2019. Even though with its intrinsic limitations, our results may be added to the most recent scientific evidence to confirm the unfavorable risk profile of hydroxychloroquine in its off-label use in the treatment of COVID-19 disease.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Long QT Syndrome
/
Drug-Related Side Effects and Adverse Reactions
/
COVID-19 Drug Treatment
Type of study:
Observational study
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
Fundam Clin Pharmacol
Journal subject:
Pharmacology
Year:
2022
Document Type:
Article
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