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Clinical and non-clinical safety of artemisinin derivatives in pregnancy

Gomes, Caroline ; Boareto, Ana Cláudia ; Dalsenter, Paulo Roberto

Reproductive toxicology (Elmsford, N.Y.), 2016-10, Vol.65, p.194-203 [Periódico revisado por pares]

United States: Elsevier Inc

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  • Título:
    Clinical and non-clinical safety of artemisinin derivatives in pregnancy
  • Autor: Gomes, Caroline ; Boareto, Ana Cláudia ; Dalsenter, Paulo Roberto
  • Assuntos: Animals ; Antimalarials - adverse effects ; Antimalarials - therapeutic use ; Artemisinin derivative ; Artemisinins - adverse effects ; Artemisinins - therapeutic use ; Clinical study ; Embryo, Mammalian - drug effects ; Embryotoxicity ; Female ; Humans ; Non-clinical study ; Pregnancy ; Prenatal Injuries - chemically induced ; Teratogens - toxicity
  • É parte de: Reproductive toxicology (Elmsford, N.Y.), 2016-10, Vol.65, p.194-203
  • Notas: ObjectType-Article-2
    SourceType-Scholarly Journals-1
    ObjectType-Feature-3
    content type line 23
    ObjectType-Review-1
  • Descrição: •Artemisinin derivatives are embryo toxic to uninfected experimental animals.•No embryotoxicity was proved in clinical studies until now.•There are species differences in the estimated sensitive period for toxicity.•The presence of malaria infection might reduce the distribution of drug to fetus.•Further researches are needed to clarify the developmental toxicity of these drugs. Malaria in pregnancy is a clinically wasting infectious disease, where drug therapy has to be promptly initiated. Currently, the treatment of this infection depends on the use of artemisinin derivatives. The World Health Organization does not recommend the use of these drugs in the first trimester of pregnancy due to non-clinical findings that have shown embryolethality and teratogenic effects. Nevertheless, until now, this toxicity has not been proved in humans. Artemisinin derivatives mechanisms of embryotoxicity are related to depletion of circulating embryonic primitive erythroblasts. Species differences in this sensitive period for toxicity and the presence of malaria infection, which could reduce drug distribution to the fetus, are significant to the risk assessment of artemisinin derivatives treatment to pregnant women. In this review we aimed to assess the results of non-clinical and clinical studies with artemisinin derivatives, their mechanisms of embryotoxicity and discuss the safety of their use during pregnancy.
  • Editor: United States: Elsevier Inc
  • Idioma: Inglês
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  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

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