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Primaquine: the risks and the benefits.

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Primaquine is crucial for malaria elimination, preventing relapses and transmission. A single low dose poses minimal hemolytic risk, even for individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

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Area of Science:

  • Malariology
  • Pharmacology
  • Genetics

Background:

  • Primaquine is the sole widely available antimalarial drug effective against relapses of *Plasmodium vivax* and *Plasmodium ovale* malaria.
  • It is also the most potent gametocytocide for *Plasmodium falciparum* malaria, crucial for blocking transmission.
  • Widespread use is hindered by concerns of hemolytic toxicity in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, a common genetic trait in malaria-endemic regions.

Purpose of the Study:

  • To evaluate the safety and efficacy of primaquine, particularly in individuals with G6PD deficiency.
  • To assess the risk of hemolytic toxicity associated with different primaquine dosing regimens.
  • To inform malaria elimination strategies by clarifying the risks and benefits of primaquine use.

Main Methods:

  • Review of published literature on primaquine use, including clinical trials and case reports.
  • Analysis of dose-response relationships for primaquine's efficacy and toxicity.
  • Estimation of mortality risk based on reported deaths and known denominators.

Main Results:

  • Over six decades and approximately 200 million people treated, 14 deaths were reported, with most linked to multiple dosing for *P. vivax* relapse prevention.
  • The estimated mortality rate is very low (1 in 621,428).
  • The currently recommended World Health Organization (WHO) single low dose (0.25 mg base/kg) for blocking *P. falciparum* transmission demonstrates a very low risk of hemolytic toxicity in G6PD-deficient individuals.

Conclusions:

  • Primaquine remains essential for malaria elimination programs, particularly for radical cure of *P. vivax* and *P. ovale*.
  • The risk of severe hemolytic toxicity with the WHO-recommended single low dose is minimal, even in G6PD-deficient populations.
  • Primaquine should be more widely administered to achieve malaria elimination goals, with careful consideration of dosing and G6PD status.