The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities

• Published in: Journal of allergy and clinical immunology Vol. 147; no. 6; pp. 2009 - 2020
• Main Authors: Chambers, Christina D., Krishnan, Jerry A., Alba, Lorene, Albano, Jessica D., Bryant, Allison S., Carver, Melanie, Cohen, Lee S., Gorodetsky, Elena, Hernandez-Diaz, Sonia, Honein, Margaret A., Jones, Bridgette L., Murray, Richard K., Namazy, Jennifer A., Sahin, Leyla, Spong, Catherine Y., Vasisht, Kaveeta P., Watt, Kevin, Wurst, Keele E., Yao, Lynne, Schatz, Michael
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2021; Elsevier Limited
• Subjects: Asthma; Asthma medication; Automation; Birth defects; Breastfeeding & lactation; Congenital diseases; Decision making; Design; Electronic health records; Electronic medical records; FDA approval; Information sources; Labeling; Lactation; Pharmaceutical industry; Pregnancy; Safety; Womens health; United States > US; FDA; APR; MFMU; Asthma medication; lactation; VAMPSS; pregnancy; GRADE
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2021.02.037

Asthma is one of the most common underlying diseases in women of reproductive age that can lead to potentially serious medical problems during pregnancy and lactation. A group of key stakeholders across multiple relevant disciplines was invited to take part in an effort to prioritize, strategize, and mobilize action steps to fill important gaps in knowledge regarding asthma medication safety in pregnancy and lactation. The stakeholders identified substantial gaps in the literature on the safety of asthma medications used during pregnancy and lactation and prioritized strategies to fill those gaps. Short-term action steps included linking data from existing complementary study designs (US and international claims data, single drug pregnancy registries, case-control studies, and coordinated systematic data systems). Long-term action steps included creating an asthma disease registry, incorporating the disease registry into electronic health record systems, and coordinating care across disciplines. The stakeholders also prioritized establishing new infrastructures/collaborations to perform research in pregnant and lactating women and to include patient perspectives throughout the process. To address the evidence gaps, and aid in populating product labels with data that inform clinical decision making, the consortium developed a plan to systematically obtain necessary data in the most efficient and timely manner.