The primary serious concern is drug-induced hemolysis in G6PD-deficient individuals.
Expert opinion on drug safety · 2 authors, 4 centres
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The primary serious concern is drug-induced hemolysis in G6PD-deficient individuals.
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.