Abstract
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.
Original language | English (US) |
---|---|
Pages (from-to) | 2009-2020 |
Number of pages | 12 |
Journal | Journal of Allergy and Clinical Immunology |
Volume | 147 |
Issue number | 6 |
DOIs | |
State | Published - Jun 2021 |
Keywords
- Asthma medication
- lactation
- pregnancy
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
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The safety of asthma medications during pregnancy and lactation : Clinical management and research priorities. / Chambers, Christina D.; Krishnan, Jerry A.; Alba, Lorene et al.
In: Journal of Allergy and Clinical Immunology, Vol. 147, No. 6, 06.2021, p. 2009-2020.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - The safety of asthma medications during pregnancy and lactation
T2 - Clinical management and research priorities
AU - Chambers, Christina D.
AU - Krishnan, Jerry A.
AU - Alba, Lorene
AU - Albano, Jessica D.
AU - Bryant, Allison S.
AU - Carver, Melanie
AU - Cohen, Lee S.
AU - Gorodetsky, Elena
AU - Hernandez-Diaz, Sonia
AU - Honein, Margaret A.
AU - Jones, Bridgette L.
AU - Murray, Richard K.
AU - Namazy, Jennifer A.
AU - Sahin, Leyla
AU - Spong, Catherine Y.
AU - Vasisht, Kaveeta P.
AU - Watt, Kevin
AU - Wurst, Keele E.
AU - Yao, Lynne
AU - Schatz, Michael
N1 - Funding Information: Disclosure of potential conflict of interest: C. D. Chambers receives research funding from Amgen, Inc, AstraZeneca, Celgene, GlaxoSmithKline, Janssen Pharmaceuticals, Pfizer, Inc, Regeneron, Hoffman La-Roche-Genentech, Genzyme Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Sanofi, UCB Pharma, USA, Sun Pharma Global FZE, and the Gerber Foundation. J. A. Krishnan received research funding from the National Institutes of Health, Patient Centered Outcomes Research Institute, Regeneron, Inogen, ResMed, and the Sergey Bring Family Foundation. J. D. Albano is an employee of Syneos Health, Morrisville, NC, and owns company stock. L. Alba and M. Carver are employed by the Asthma and Allergy Foundation of America, a nonprofit patient organization, which has received grants for research and unbranded initiatives from Amgen, Amphastar, AstraZeneca, Boehinger Ingelheim, Genentech/Roche, GlaxoSmithKline, Mylan, Novartis, Regeneron, Sanofi Genzyme, and Teva. L. Alba has also received honoraria from serving on the AstraZeneca patient partnership program. S. Hernandez-Diaz reports being an investigator on grants to her institution from GlaxoSmithKline and Takeda for unrelated studies; personal fees from UCB and Roche outside the submitted work; and having served as an epidemiologist with the North America AED pregnancy registry, which is funded by multiple companies. L. S. Cohen receives research support from National Pregnancy Registry for Atypical Antipsychotics: Alkermes Biopharmaceuticals, AstraZeneca Pharmaceuticals, Forest/Actavis Pharmaceuticals, Ortho-McNeil Janssen Pharmaceuticals, Inc, Otsuka Pharmaceuticals, Sunovion Pharmaceuticals, Inc, Teva Pharmaceuticals, and Johnson and Johnson and receives other research support from Brain & Behavior Research Foundation, JayMac Pharmaceuticals, National Institute on Aging, National Institutes of Health, National Institute of Mental Health, SAGE Therapeutics, Takeda/Lundbeck Pharmaceuticals Advisory/Consulting: Alkermes Biopharmaceuticals (through MGH Clinical Trials Network Initiative), JDS Therapeutics LLC, and Praxis Precision Medicines, Inc (through MGH Clinical Trials Network Initiative). B. L. Jones receives authorship fees from The Merck Manuals (Merck & Co) and grant funding support from National Institutes of Health (grant nos. 1 R01 HD100545-01 and 1R01MD015409-01). K. E. Wurst is employed by and holds stock/shares in GlaxoSmithKline. L. Yao is employed by the US Food and Drug Administration. J. A. Namazy has received funding as a speaker for GlaxoSmithKline. M. Schatz receives research grant support paid to his institution from ALK, Merck, and Teva and receives honoraria from UpToDate and a stipend from the American Academy of Allergy, Asthma, and Immunology for his role as Editor-in-Chief of the Journal of Allergy and Clinical Immunology: In Practice. The rest of the authors declare that they have no relevant conflicts of interest. Funding Information: This study was supported by the National Institutes of Health (grant/award no. R13HL149440 to C.C.), the National Institutes of Health Office of Research on Women’s Health , and the US Food & Drug Administration Office of Women’s Health . Funding Information: This study was supported by the National Institutes of Health (grant/award no. R13HL149440 to C.C.), the National Institutes of Health Office of Research on Women's Health, and the US Food & Drug Administration Office of Women's Health. Disclosure of potential conflict of interest: C. D. Chambers receives research funding from Amgen, Inc, AstraZeneca, Celgene, GlaxoSmithKline, Janssen Pharmaceuticals, Pfizer, Inc, Regeneron, Hoffman La-Roche-Genentech, Genzyme Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Sanofi, UCB Pharma, USA, Sun Pharma Global FZE, and the Gerber Foundation. J. A. Krishnan received research funding from the National Institutes of Health, Patient Centered Outcomes Research Institute, Regeneron, Inogen, ResMed, and the Sergey Bring Family Foundation. J. D. Albano is an employee of Syneos Health, Morrisville, NC, and owns company stock. L. Alba and M. Carver are employed by the Asthma and Allergy Foundation of America, a nonprofit patient organization, which has received grants for research and unbranded initiatives from Amgen, Amphastar, AstraZeneca, Boehinger Ingelheim, Genentech/Roche, GlaxoSmithKline, Mylan, Novartis, Regeneron, Sanofi Genzyme, and Teva. L. Alba has also received honoraria from serving on the AstraZeneca patient partnership program. S. Hernandez-Diaz reports being an investigator on grants to her institution from GlaxoSmithKline and Takeda for unrelated studies; personal fees from UCB and Roche outside the submitted work; and having served as an epidemiologist with the North America AED pregnancy registry, which is funded by multiple companies. L. S. Cohen receives research support from National Pregnancy Registry for Atypical Antipsychotics: Alkermes Biopharmaceuticals, AstraZeneca Pharmaceuticals, Forest/Actavis Pharmaceuticals, Ortho-McNeil Janssen Pharmaceuticals, Inc, Otsuka Pharmaceuticals, Sunovion Pharmaceuticals, Inc, Teva Pharmaceuticals, and Johnson and Johnson and receives other research support from Brain & Behavior Research Foundation, JayMac Pharmaceuticals, National Institute on Aging, National Institutes of Health, National Institute of Mental Health, SAGE Therapeutics, Takeda/Lundbeck Pharmaceuticals Advisory/Consulting: Alkermes Biopharmaceuticals (through MGH Clinical Trials Network Initiative), JDS Therapeutics LLC, and Praxis Precision Medicines, Inc (through MGH Clinical Trials Network Initiative). B. L. Jones receives authorship fees from The Merck Manuals (Merck & Co) and grant funding support from National Institutes of Health (grant nos. 1 R01 HD100545-01 and 1R01MD015409-01). K. E. Wurst is employed by and holds stock/shares in GlaxoSmithKline. L. Yao is employed by the US Food and Drug Administration. J. A. Namazy has received funding as a speaker for GlaxoSmithKline. M. Schatz receives research grant support paid to his institution from ALK, Merck, and Teva and receives honoraria from UpToDate and a stipend from the American Academy of Allergy, Asthma, and Immunology for his role as Editor-in-Chief of the Journal of Allergy and Clinical Immunology: In Practice. The rest of the authors declare that they have no relevant conflicts of interest. Publisher Copyright: © 2021 American Academy of Allergy, Asthma & Immunology
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - Asthma medication
KW - lactation
KW - pregnancy
UR - http://www.scopus.com/inward/record.url?scp=85107902451&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85107902451&partnerID=8YFLogxK
U2 - 10.1016/j.jaci.2021.02.037
DO - 10.1016/j.jaci.2021.02.037
M3 - Article
C2 - 33713765
AN - SCOPUS:85107902451
VL - 147
SP - 2009
EP - 2020
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
SN - 0091-6749
IS - 6
ER -