SEARCHSYSTEMATIC_REVIEWinfectious disease, public health

systematic_review·infectious disease, public health, systematic review, meta-analysis, clinical trial·PMC10591488

Tafenoquine: a toxicity overview

Expert opinion on drug safety · 2 authors, 4 centres

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FIDELITY 100%

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TL;DR

The primary serious concern is drug-induced hemolysis in G6PD-deficient individuals.

Full summary

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This systematic review and meta-analysis assessed adverse events from English-language human clinical trials of tafenoquine. Twenty-four studies contributed data for meta-analysis, comparing tafenoquine to placebo, chloroquine, or primaquine across various dosing regimens. Central results show tafenoquine did not significantly increase the risk of neuropsychiatric symptoms compared to controls. Ocular effects were dose-dependent vortex keratopathy, which was generally mild, reversible, and did not differentially affect vision compared to comparators like chloroquine. No convincing evidence for neurologic, ophthalmic, or cardiac toxicities was found. The review highlights that psychotic disorder is a contraindication for the prophylaxis indication, and pregnancy assessment and quantitative G6PD testing are required. Limitations include the heterogeneous data collection methods for neuropsychiatric symptoms across included studies. The implications are that tafenoquine is a generally well-tolerated option for vivax malaria, but its use requires careful screening.

STUDY TYPE

systematic_review

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infectious disease

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AI pipeline

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100% · A

ORIGINAL PAPER

PMC10591488

Tafenoquine: a toxicity overview

Expert opinion on drug safety

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ABSTRACT

Abstract Introduction: A century-long history in 8-aminoquinolines, the only anti-malaria drug class preventing malaria relapse, has resulted in the approval of tafenoquine by the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) and to date registration in Brazil and Thailand. Tafenoquine is an alternative anti-relapse treatment for vivax malaria and malaria prophylaxis. It should not be given in pregnancy, during lactation of infants with glucose-6-phosphate dehydrogenase (G6PD) unknown or deficient status, and in those with G6PD deficiency or psychiatric illness. Areas covered: This systematic review assesses tafenoquine associated adverse events in English-language, human clinical trials. Meta-analysis of commonly reported adverse events was conducted and grouped by comparison arms. Expert opinion: Tafenoquine, either for radical cure or prophylaxis, is generally well tolerated in adults. There is no convincing evidence for neurologic, ophthalmic, and cardiac toxicities. Psychotic disorder which has been attributed to higher doses is a contraindication for the chemoprophylaxis indication and psychiatric illness is a warning for the radical cure indication. Pregnancy assessment and quantitative G6PD testing are required. The optimal radical curative regimen including the tafenoquine dose along with its safety for parts of Southeast Asia, South America, and Oceania needs further assessment. Keywords: 8-aminoquinoline, adverse effect, causal prophylaxis, chemoprophylaxis, radical cure, meta-analysis, plasmodium vivax, relapse prevention, drug safety, tafenoquine

CITATION EXPORT

Cindy S Chu, Jimee Hwang. Tafenoquine: a toxicity overview. Expert opinion on drug safety. (2021). https://doi.org/10.1080/14740338.2021.1859476

AUTHORS

2 · 4 CENTRES

Cindy S Chu, Jimee Hwang

aShoklo Malaria Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand
bCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, UK
cU.S. President’s Malaria Initiative, Malaria Branch, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA
dGlobal Health Group, University of California San Francisco, San Francisco, CA, USA