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Safety and Pharmacovigilance of Herbal Medicines in Pregnancy

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Pharmacovigilance for Herbal and Traditional Medicines
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Abstract

The use of herbal medicines in pregnancy is common despite the lack of efficacy and safety data for these products. Pregnant women are often not aware that herbal preparations may be harmful in pregnancy and are often encouraged to use ‘natural’ products, such as herbal medicines, rather than pharmaceuticals, as herbal products are perceived as being safer. However, plant-based medicines can cause adverse reactions and can be highly toxic to pregnant women. Healthcare providers should establish, in non-judgmental and culturally appropriate ways, whether women are using herbal medicines, or other ‘natural’ or traditional medicines in pregnancy, and should report, or encourage reporting of, ongoing exposed pregnancies and adverse maternal and foetal events associated with use of such products to an appropriate reporting system, if available.

There is a need for evidence-based information regarding the use of most herbal medicines in pregnancy for both women and their healthcare providers. With the exception of certain ginger root extracts, there are no consistent data to support the use of any other herbal supplement during pregnancy and such products should not be recommended.

Current methods of research into the safety of herbal medicine use in pregnancy suffer from several methodological limitations, some of which can be overcome with novel methods of data collection. Collection of data directly from pregnant women allows the opportunity for a much more complete record of prescription, and non-prescription medicine use, including herbal medicines and other ‘natural’ health products, as well as the use of recreational drugs and alcohol use. Web- or app-based data collection can also be utilised in countries where national adverse reaction spontaneous reporting systems or registries are not available.

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Stephens, S. (2022). Safety and Pharmacovigilance of Herbal Medicines in Pregnancy. In: Barnes, J. (eds) Pharmacovigilance for Herbal and Traditional Medicines. Adis, Cham. https://doi.org/10.1007/978-3-031-07275-8_6

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