How to use medicinal products during pregnancy

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The majority of medicinal products or chemical substances administered to a pregnant woman could have effects on the fetus to at least some extent in any stage of the pregnancy. Medicinal products could also have different effects at different stages of the pregnancy.

Problem lies in limited information on use and safety profiles of medicinal products in pregnant women. Researchers will in most cases, collect this data if products intended usage is specifically during pregnancy. In other cases, clinical trial of medicinal product under development rarely includes pregnant women.

Essential role of Pharmacovigilance data

Pharmacovigilance data, especially during post-marketing period, is essential to collect when there is use of medicinal products in pregnant women. In order to evaluate risk-benefit ratio of medicinal products during pregnancy we need data which should be collected as an unapproved indication – intentional or unintentional. This data will also improve safety profile of medicinal products.

This data refers not only to pregnant women, but also to women in childbearing age who experienced unplanned pregnancies. Data should also be collected for men who are taking medicinal products due possible effects on the fetus via semen.

Minimizing risks

Taking all of this into consideration, in order to minimize the fetal risk of exposure, it is important to restrict drug therapy of the mother as well as gather information on medicinal products taken by pregnant women if the therapy is necessary.

Mirjam Glassner Doko

PVO, Clinres farmacija

Reference:

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-exposure-medicinal-products-during-pregnancy-need-post-authorisation-data_en.pdf

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