Drug safety studies in pregnancy based on data from regulatory information sources: a systematic review

Relevance. Prenatal exposure to medicines with a teratogenic risk and the prevention of such exposure is an important clinical and public health issue. The first priority for the safe use of medicines, both during pregnancy and by women of reproductive age, is to know the teratogenic risk and to include it in the primary source of information. Objective. To conduct a systematic literature review to identify and compare the results of drug safety studies in pregnancy based on data from officially recognised information documents. Material and methods. Literature searches were conducted in the electronic databases MEDLINE/PubMed from 1 January 2000 to 30 June 2024, using specific keywords and MeSH (Medical Subject Headings) terms in combination with the logical operators "AND" and "OR". The Google Scholar search engine has also been used for the manual selection of publications. Results. The search identified 24 publications that were relevant to the topic under study and were included in the analysis. Studies in regulatory documents assessing the completeness, applicability and safety of information on the use of the drug in pregnancy (n = 3; 12.5 %) revealed a lack of sufficient data on people. Comparative studies of inconsistencies between different sources of information (n = 10; 41.7 %) showed inconsistencies between countries in the content of information on medicines produced by the same pharmaceutical companies, as well as differences between different sources of approved information. A number of studies (n = 5; 20.8 %) focus on current systems of risk classification in pregnancy, the effectiveness of prescribing information to warn of the teratogenicity of medicines and the adaptation of its content to the level of risk perception. In the United States, prescription information is divided into specific subsections, the content of which is regulated by the recently published Pregnancy and Lactation Labeling Rule, which was the focus of several studies (n = 6; 25.0 %). Conclusion. The increasing use of medicines in pregnancy worldwide and the annual registration of new medicines, most of which contain limited or no safety information in pregnancy, support the relevance of this systematic review.