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

Year 2025, Volume: 3 Issue: 1, 19 - 26, 30.04.2025

Nesrin Çağlayan Duman , Nevsun İnanç , Atila Karaalp

https://doi.org/10.62425/rtpharma.1642361

Abstract

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.

Keywords

pregnancy , lactation , patient information leaflet , antirheumatic drug

Ethical Statement

No ethical approval was required as TİTCK is an anonymised open database.

Supporting Institution

Not avaliable

References

• Arsalan, A., Qureshi, S., Alam, M., Ahmed, S., Shakeel, O., Ali, A., & Jabeen, W. (2015). Errors in Patients’ Information Leaflets of Marketed Medicines in Pakistan. Journal of Applied Pharmaceutical Science, 068–074. https://doi.org/10.7324/JAPS.2015.50513
• Birru Talabi, M., & Clowse, M. E. B. (2020). Antirheumatic medications in pregnancy and breastfeeding. Current Opinion in Rheumatology, 32(3), 238–246. https://doi.org/10.1097/BOR.0000000000000710
• Bjerrum, L., & Foged, A. (2003). Patient information leaflets-helpful guidance or a source of confusion? Pharmacoepidemiology and Drug Safety, 12(1), 55–59. https://doi.org/10.1002/pds.795
• Brooks, P. M., & Needs, C. J. (1990). Antirheumatic drugs in pregnancy and lactation. Baillière’s Clinical Rheumatology, 4(1), 157–171. https://doi.org/10.1016/S0950-3579(05)80249-3
• Brown, E., Hotham, E., & Hotham, N. (2016). Pregnancy and lactation advice: How does Australian Product Information compare with established information resources? Obstetric Medicine, 9(3), 130–134. https://doi.org/10.1177/1753495X16637750
• Crunkhorn, C., van Driel, M., Nguyen, V., & McGuire, T. (2017). Children’s medicine: What do consumers really want to know? Journal of Paediatrics and Child Health, 53(2), 155–162. https://doi.org/10.1111/jpc.13339
• Desai, R. J., Huybrechts, K. F., Bateman, B. T., Hernandez‐Diaz, S., Mogun, H., Gopalakrishnan, C., Patorno, E., & Kim, S. C. (2016). Brief Report: Patterns and Secular Trends in Use of Immunomodulatory Agents During Pregnancy in Women With Rheumatic Conditions. Arthritis & Rheumatology, 68(5), 1183–1189. https://doi.org/10.1002/art.39521
• European Medicines Agency. (2009). Information on benefit-risk of medicines: patients’, consumers’ and healthcare professionals’ expectations. https://www.ema.europa.eu/en/documents/other/information-benefit-risk-medicines-patients-consumers-healthcare-professionals-expectations_en.pdf
• Flint, J., Panchal, S., Hurrell, A., van de Venne, M., Gayed, M., Schreiber, K., Arthanari, S., Cunningham, J., Flanders, L., Moore, L., Crossley, A., Purushotham, N., Desai, A., Piper, M., Nisar, M., Khamashta, M., Williams, D., Gordon, C., & Giles, I. (2016). BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding—Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids: Table 1. Rheumatology, 55(9), 1693–1697. https://doi.org/10.1093/rheumatology/kev404
• Gerardi, M. C., Crisafulli, F., García-Fernandez, A., Lini, D., Bazzani, C., Cavazzana, I., Filippini, M., Fredi, M., Gorla, R., Lazzaroni, M. G., Nalli, C., Taglietti, M., Lojacono, A., Ramazzotto, F., Zanardini, C., Zatti, S., Franceschini, F., Tincani, A., & Andreoli, L. (2022). Stopping bDMARDs at the beginning of pregnancy is associated with disease flares and preterm delivery in women with rheumatoid arthritis. Frontiers in Pharmacology, 13. https://doi.org/10.3389/fphar.2022.887462
• Giles, I., Yee, C.-S., & Gordon, C. (2019). Stratifying management of rheumatic disease for pregnancy and breastfeeding. Nature Reviews Rheumatology, 15(7), 391–402. https://doi.org/10.1038/s41584-019-0240-8
• Götestam Skorpen, C., Hoeltzenbein, M., Tincani, A., Fischer-Betz, R., Elefant, E., Chambers, C., da Silva, J., Nelson-Piercy, C., Cetin, I., Costedoat-Chalumeau, N., Dolhain, R., Förger, F., Khamashta, M., Ruiz-Irastorza, G., Zink, A., Vencovsky, J., Cutolo, M., Caeyers, N., Zumbühl, C., & Østensen, M. (2016). The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Annals of the Rheumatic Diseases, 75(5), 795–810. https://doi.org/10.1136/annrheumdis-2015-208840
• Hailu, H. G., Gobezie, M. Y., Tuem, K. B., Gebremichael, H. T., & Mohammed, S. A. (2022). Evaluation of Medication Package Inserts in Ethiopia. Journal of Environmental and Public Health, 2022, 1–7. https://doi.org/10.1155/2022/8299218
• He, W. R., & Wei, H. (2020). Maternal and fetal complications associated with systemic lupus erythematosus. Medicine, 99(16), e19797. https://doi.org/10.1097/MD.0000000000019797
• Ince-Askan, H., Hazes, J. M. W., & Dolhain, R. J. E. M. (2019). Breastfeeding among Women with Rheumatoid Arthritis Compared with the General Population: Results from a Nationwide Prospective Cohort Study. The Journal of Rheumatology, 46(9), 1067–1074. https://doi.org/10.3899/jrheum.180805
• Kemper, E., Ghalandari, N., Wintjes, H., Van Steensel-Boon, A., Kranenburg, L., Mulders, A., Crijns, H., Smeele, H., & Dolhain, R. J. E. (2022). Active counselling and well-controlled disease result in a higher percentage of women with rheumatoid arthritis that breast feed: results from the PreCARA study. RMD Open, 8(2), e002194. https://doi.org/10.1136/rmdopen-2022-002194
• Khamas, S., Jafari, A., Zarif-Yeganeh, M., & Taghvaye-Masoumi, H. (2019). Evaluation of medication package inserts in Iran. Journal of Research in Pharmacy Practice, 8(2), 45. https://doi.org/10.4103/jrpp.JRPP_18_32
• Ørnbjerg, L. M., Andersen, H. B., Kryger, P., Cleal, B., & Hetland, M. L. (2008). What Do Patients in Rheumatologic Care Know About the Risks of NSAIDs? JCR: Journal of Clinical Rheumatology, 14(2), 69–73. https://doi.org/10.1097/RHU.0b013e31816b1e8e
• Rebić, N., Sayre, E. C., Zusman, E. Z., Amiri, N., Baldwin, C., & De Vera, M. A. (2020). Perinatal use and discontinuation of disease-modifying anti-rheumatic drugs and biologics in women with rheumatoid arthritis: a cohort study. Rheumatology, 59(7), 1514–1521. https://doi.org/10.1093/rheumatology/kez478
• Sabando, M. O., Saavedra, M. A., Sequeira, G., & Kerzberg, E. (2018). Analysis of the data on pregnancy and lactation provided by patient information leaflets of anti-rheumatic drugs in Argentina. Rheumatology International, 38(4), 669–673. https://doi.org/10.1007/s00296-018-3931-6
• Sim, B. L., Daniel, R. S., Hong, S. S., Matar, R. H., Ganiel, I., Nakanishi, H., Mansour, R., Than, C. A., & Alrahmani, L. (2023). Pregnancy Outcomes in Women With Rheumatoid Arthritis. JCR: Journal of Clinical Rheumatology, 29(1), 36–42. https://doi.org/10.1097/RHU.0000000000001935
• Turkish Medicines and Medical Devices Agency. (2008, February 26). Kullanma Talimatı Standart Değerlendirme Prosedürü. https://www.titck.gov.tr/mevzuat/kullanma-talimati-standart-degerlendirme-proseduru-27122018172808
• van den Brandt, S., Zbinden, A., Baeten, D., Villiger, P. M., Østensen, M., & Förger, F. (2017). Risk factors for flare and treatment of disease flares during pregnancy in rheumatoid arthritis and axial spondyloarthritis patients. Arthritis Research & Therapy, 19(1), 64. https://doi.org/10.1186/s13075-017-1269-1.