Abstract
Because pregnant women are routinely excluded from pre-licensure clinical trials for fear of 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.
Highlights
SÈ 4HEÈARTEMISININSÈAREÈEFFECTIVEÈ antimalarials increasingly deployed in malaria-endemic countries; they have been shown to be embryotoxic in animal models, and their safety in early human pregnancies remains uncertain
This paper describes the use of pregnancy exposure registry (PER) as a targeted pharmacovigilance approach for assessing the safety of antimalarial drugs used during early pregnancy in resource-constrained malaria-endemic countries
Internal comparison groups can consist of women with the same conditions who are unexposed to drugs, exposed to a different drug with established safety, or exposed to the same investigational drug, but only outside the critical period
Summary
Because pregnant women are routinely excluded from prelicensure clinical trials for fear of harming the mother or the developing foetus [1], most drugs are marketed with limited information on their safety during pregnancy and are not recommended for use by pregnant women. 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), if there have been case reports of adverse pregnancy outcome following exposure, if drugs in the same pharmacological class are known to pose risk during pregnancy, or if pre-clinical animal data suggest potential teratogenic risk [3,4] In industrialised countries, this information can be derived from medical records and automated databases, including medical or pharmacy insurance claims. Pregnant women, and policy makers urgently need valid information to make informed decisions about the risks and benefits of ACTs for WOCBAs. This paper describes the use of PERs as a targeted pharmacovigilance approach for assessing the safety of antimalarial drugs used during early pregnancy in resource-constrained malaria-endemic countries
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