Evaluation of information on pregnancy and lactation in patient information leaflets of antirheumatic drugs

Le résumé fourni par la source

Objective: The use of antirheumatic drugs during pregnancy and lactation should be arranged so as not to harm the fetus and mother. There are various sources of information, such as pregnancy guidelines and patient information leaflet (PIL), which are used to determine the course of treatment during these periods. Methods: In this study, different antirheumatic drug PILs were evaluated in terms of the inconsistency of their information on the use of drugs during pregnancy and lactation with the current The European League Against Rheumatism (EULAR) guidelines. Inconsistent PILs were categorized into 2 different groups according to their information on the use of the drug during pregnancy and lactation: I. lack of information and II. Conflict or contrary of information. Results: It was found that 72.1% of the 179 PILs had inconsistent pregnancy information (lack of information n=22, conflict or contrary of information n=107) and 75.4% had inconsistent lactation information (lack of information n=22, conflict or contrary of information n=113) compared with EULAR. According to the EULAR, 79.3% (n=142) of the drugs in this study were suitable for use in pregnancy and 80.4% (n=144) were suitable for use during lactation. Conclusion: The findings of this study draw attention to the need for national and international regulation to harmonize the information in PILs with the current literature. This study will be useful for patients and healthcare professionals to ensure that PILs are compatible with the current literature.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.