Pregnancy Exposure Registries for Assessing Antimalarial Drug Safety in Pregnancy in Malaria-Endemic Countries 英文参考文献.docVIP

Health in Action Pregnancy Exposure Registries for Assessing Antimalarial Drug Safety in Pregnancy in Malaria-Endemic Countries Stephanie Dellicour, Feiko O. ter Kuile*, Andy Stergachis B ecause pregnant women are routinely excluded from pre- licensure clinical trials for fear of diseases, as these are not widely used in the countries with more robust pharmacovigilance systems [9]. Summary Points sè 4HEREèISèANèURGENTèNEEDèTOèDEVELOPè targeted pharmacovigilance systems to assess the safety of antimalarials in early pregnancy. harming the mother or the developing foetus [1], most drugs are marketed with limited information on their safety during pregnancy and therefore are not recommended for use by pregnant women. Yet drugs are widely used by pregnant women, and medication often cannot be avoided in chronic diseases such as epilepsy and HIV or other acute illness that harm the mother and the unborn child if left untreated. Antimalarials are a good example [9]. Malaria can have devastating consequences for the mother and foetus [10,11], and pregnant women require prompt treatment with safe and effective antimalarial drugs when infected. The artemisinins are among the most effective and rapidly acting antimalarials to date, providing life- saving benefits to children, adults, and sè 4HEèARTEMISININSèAREèEFFECTIVEè antimalarials increasingly deployed in malaria-endemic countries; however, they have been shown to be embryo- toxic in animal models, and their safety in early human pregnancies remains uncertain. sè -ODELLINGèSUGGESTSèTHATèTHEè Passive mechanisms of spontaneous reporting of adverse drug effects are inadequate for detecting drug- induced foetal risks or lack of such risks [2]. The US Food and Drug Administration and the European Medicine Agency recommend active surveillance, such as the use of pregnancy exposure registries (PERs), for products that are likely to be used during pregnancy or by women of childbearing age (WOCBAs), particularly