Hydroxychloroquine early in pregnancy and risk of birth defects.
Identifieur interne : 000B73 ( Main/Corpus ); précédent : 000B72; suivant : 000B74Hydroxychloroquine early in pregnancy and risk of birth defects.
Auteurs : Krista F. Huybrechts ; Brian T. Bateman ; Yanmin Zhu ; Loreen Straub ; Helen Mogun ; Seoyoung C. Kim ; Rishi J. Desai ; Sonia Hernandez-DiazSource :
- American journal of obstetrics and gynecology [ 1097-6868 ] ; 2021.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Hydroxychloroquine.
- drug therapy : Pregnancy Complications.
- etiology : Abnormalities, Drug-Induced.
- prevention & control : COVID-19.
- Adult, Female, Humans, Pregnancy, SARS-CoV-2.
Abstract
BACKGROUND
Hydroxychloroquine is generally considered safe in pregnancy for the treatment of rheumatic conditions, but studies have been too small to evaluate teratogenicity. Quantifying the risk of congenital malformations associated with early pregnancy exposure to hydroxychloroquine is important in both the context of its ongoing use for rheumatological disorders and its potential future use for coronavirus disease 2019 prophylaxis, for which a number of clinical trials are ongoing despite initial trials for coronavirus disease 2019 treatment having been negative.
OBJECTIVE
The study objective was to evaluate the risk of major congenital malformations associated with exposure to hydroxychloroquine during the first trimester of pregnancy, the period of organogenesis.
STUDY DESIGN
We performed a population-based cohort study nested in the Medicaid Analytic eXtract (MAX, 2000-2014) and IBM MarketScan Research Database (MarketScan, 2003-2015). The source cohort included 2045 hydroxychloroquine-exposed pregnancies and 3,198,589 pregnancies not exposed to hydroxychloroquine continuously enrolled in their respective insurance program for 3 months before the last menstrual period through at least 1 month after delivery; infants were enrolled for at least 3 months after birth. We compared the risk of congenital malformations in women using hydroxychloroquine during the first trimester of pregnancy with that of those not using hydroxychloroquine, restricting the cohort to women with rheumatic disorders and using propensity score matching to control for indication, demographics, medical comorbidities, and concomitant medications (1867 hydroxychloroquine-exposed pregnancies and 19,080 pregnancies not exposed to hydroxychloroquine). The outcomes considered included major congenital malformations diagnosed during the first 90 days after delivery and specific malformation types for which there were at least 5 exposed events: oral cleft, cardiac, respiratory, gastrointestinal, genital, urinary, musculoskeletal, and limb defects.
RESULTS
Overall, 54.8 per 1000 infants exposed to hydroxychloroquine were born with a major congenital malformation versus 35.3 per 1000 unexposed infants, corresponding to an unadjusted relative risk of 1.51 (95% confidence interval, 1.27-1.81). Patient characteristics were balanced in the restricted, propensity score-matched cohort. The adjusted relative risk was 1.26 (95% confidence interval, 1.04-1.54); it was 1.33 (95% confidence interval, 1.08-1.65) for a daily dose of ≥400 mg and 0.95 (95% confidence interval, 0.60-1.50) for a daily dose of <400 mg. Among the different malformation groups considered, more substantial increases in the risk of oral clefts, respiratory anomalies, and urinary defects were observed, although estimates were imprecise. No pattern of malformation was identified.
CONCLUSION
Our findings suggest a small increase in the risk of malformations associated with first-trimester hydroxychloroquine use. For most patients with autoimmune rheumatic disorders, the benefits of treatment during pregnancy will likely outweigh this risk. If hydroxychloroquine were shown to be effective for coronavirus disease 2019 prophylaxis in ongoing trials, the risk of malformations would need to be balanced against such benefits.
DOI: 10.1016/j.ajog.2020.09.007
PubMed: 32961123
PubMed Central: PMC7501839
Links to Exploration step
pubmed:32961123Le document en format XML
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<author><name sortKey="Mogun, Helen" sort="Mogun, Helen" uniqKey="Mogun H" first="Helen" last="Mogun">Helen Mogun</name>
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<author><name sortKey="Kim, Seoyoung C" sort="Kim, Seoyoung C" uniqKey="Kim S" first="Seoyoung C" last="Kim">Seoyoung C. Kim</name>
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<author><name sortKey="Hernandez Diaz, Sonia" sort="Hernandez Diaz, Sonia" uniqKey="Hernandez Diaz S" first="Sonia" last="Hernandez-Diaz">Sonia Hernandez-Diaz</name>
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<author><name sortKey="Bateman, Brian T" sort="Bateman, Brian T" uniqKey="Bateman B" first="Brian T" last="Bateman">Brian T. Bateman</name>
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<author><name sortKey="Zhu, Yanmin" sort="Zhu, Yanmin" uniqKey="Zhu Y" first="Yanmin" last="Zhu">Yanmin Zhu</name>
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<term>Adult (MeSH)</term>
<term>COVID-19 (prevention & control)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (adverse effects)</term>
<term>Pregnancy (MeSH)</term>
<term>Pregnancy Complications (drug therapy)</term>
<term>SARS-CoV-2 (MeSH)</term>
</keywords>
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<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>Hydroxychloroquine is generally considered safe in pregnancy for the treatment of rheumatic conditions, but studies have been too small to evaluate teratogenicity. Quantifying the risk of congenital malformations associated with early pregnancy exposure to hydroxychloroquine is important in both the context of its ongoing use for rheumatological disorders and its potential future use for coronavirus disease 2019 prophylaxis, for which a number of clinical trials are ongoing despite initial trials for coronavirus disease 2019 treatment having been negative.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b>
</p>
<p>The study objective was to evaluate the risk of major congenital malformations associated with exposure to hydroxychloroquine during the first trimester of pregnancy, the period of organogenesis.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>STUDY DESIGN</b>
</p>
<p>We performed a population-based cohort study nested in the Medicaid Analytic eXtract (MAX, 2000-2014) and IBM MarketScan Research Database (MarketScan, 2003-2015). The source cohort included 2045 hydroxychloroquine-exposed pregnancies and 3,198,589 pregnancies not exposed to hydroxychloroquine continuously enrolled in their respective insurance program for 3 months before the last menstrual period through at least 1 month after delivery; infants were enrolled for at least 3 months after birth. We compared the risk of congenital malformations in women using hydroxychloroquine during the first trimester of pregnancy with that of those not using hydroxychloroquine, restricting the cohort to women with rheumatic disorders and using propensity score matching to control for indication, demographics, medical comorbidities, and concomitant medications (1867 hydroxychloroquine-exposed pregnancies and 19,080 pregnancies not exposed to hydroxychloroquine). The outcomes considered included major congenital malformations diagnosed during the first 90 days after delivery and specific malformation types for which there were at least 5 exposed events: oral cleft, cardiac, respiratory, gastrointestinal, genital, urinary, musculoskeletal, and limb defects.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Overall, 54.8 per 1000 infants exposed to hydroxychloroquine were born with a major congenital malformation versus 35.3 per 1000 unexposed infants, corresponding to an unadjusted relative risk of 1.51 (95% confidence interval, 1.27-1.81). Patient characteristics were balanced in the restricted, propensity score-matched cohort. The adjusted relative risk was 1.26 (95% confidence interval, 1.04-1.54); it was 1.33 (95% confidence interval, 1.08-1.65) for a daily dose of ≥400 mg and 0.95 (95% confidence interval, 0.60-1.50) for a daily dose of <400 mg. Among the different malformation groups considered, more substantial increases in the risk of oral clefts, respiratory anomalies, and urinary defects were observed, although estimates were imprecise. No pattern of malformation was identified.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSION</b>
</p>
<p>Our findings suggest a small increase in the risk of malformations associated with first-trimester hydroxychloroquine use. For most patients with autoimmune rheumatic disorders, the benefits of treatment during pregnancy will likely outweigh this risk. If hydroxychloroquine were shown to be effective for coronavirus disease 2019 prophylaxis in ongoing trials, the risk of malformations would need to be balanced against such benefits.</p>
</div>
</front>
</TEI>
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<Title>American journal of obstetrics and gynecology</Title>
<ISOAbbreviation>Am J Obstet Gynecol</ISOAbbreviation>
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<ArticleTitle>Hydroxychloroquine early in pregnancy and risk of birth defects.</ArticleTitle>
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<Abstract><AbstractText Label="BACKGROUND">Hydroxychloroquine is generally considered safe in pregnancy for the treatment of rheumatic conditions, but studies have been too small to evaluate teratogenicity. Quantifying the risk of congenital malformations associated with early pregnancy exposure to hydroxychloroquine is important in both the context of its ongoing use for rheumatological disorders and its potential future use for coronavirus disease 2019 prophylaxis, for which a number of clinical trials are ongoing despite initial trials for coronavirus disease 2019 treatment having been negative.</AbstractText>
<AbstractText Label="OBJECTIVE">The study objective was to evaluate the risk of major congenital malformations associated with exposure to hydroxychloroquine during the first trimester of pregnancy, the period of organogenesis.</AbstractText>
<AbstractText Label="STUDY DESIGN">We performed a population-based cohort study nested in the Medicaid Analytic eXtract (MAX, 2000-2014) and IBM MarketScan Research Database (MarketScan, 2003-2015). The source cohort included 2045 hydroxychloroquine-exposed pregnancies and 3,198,589 pregnancies not exposed to hydroxychloroquine continuously enrolled in their respective insurance program for 3 months before the last menstrual period through at least 1 month after delivery; infants were enrolled for at least 3 months after birth. We compared the risk of congenital malformations in women using hydroxychloroquine during the first trimester of pregnancy with that of those not using hydroxychloroquine, restricting the cohort to women with rheumatic disorders and using propensity score matching to control for indication, demographics, medical comorbidities, and concomitant medications (1867 hydroxychloroquine-exposed pregnancies and 19,080 pregnancies not exposed to hydroxychloroquine). The outcomes considered included major congenital malformations diagnosed during the first 90 days after delivery and specific malformation types for which there were at least 5 exposed events: oral cleft, cardiac, respiratory, gastrointestinal, genital, urinary, musculoskeletal, and limb defects.</AbstractText>
<AbstractText Label="RESULTS">Overall, 54.8 per 1000 infants exposed to hydroxychloroquine were born with a major congenital malformation versus 35.3 per 1000 unexposed infants, corresponding to an unadjusted relative risk of 1.51 (95% confidence interval, 1.27-1.81). Patient characteristics were balanced in the restricted, propensity score-matched cohort. The adjusted relative risk was 1.26 (95% confidence interval, 1.04-1.54); it was 1.33 (95% confidence interval, 1.08-1.65) for a daily dose of ≥400 mg and 0.95 (95% confidence interval, 0.60-1.50) for a daily dose of <400 mg. Among the different malformation groups considered, more substantial increases in the risk of oral clefts, respiratory anomalies, and urinary defects were observed, although estimates were imprecise. No pattern of malformation was identified.</AbstractText>
<AbstractText Label="CONCLUSION">Our findings suggest a small increase in the risk of malformations associated with first-trimester hydroxychloroquine use. For most patients with autoimmune rheumatic disorders, the benefits of treatment during pregnancy will likely outweigh this risk. If hydroxychloroquine were shown to be effective for coronavirus disease 2019 prophylaxis in ongoing trials, the risk of malformations would need to be balanced against such benefits.</AbstractText>
<CopyrightInformation>Copyright © 2020 Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Huybrechts</LastName>
<ForeName>Krista F</ForeName>
<Initials>KF</Initials>
<AffiliationInfo><Affiliation>Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA. Electronic address: khuybrechts@bwh.harvard.edu.</Affiliation>
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<Author ValidYN="Y"><LastName>Bateman</LastName>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Zhu</LastName>
<ForeName>Yanmin</ForeName>
<Initials>Y</Initials>
<AffiliationInfo><Affiliation>Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Straub</LastName>
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</AffiliationInfo>
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</AffiliationInfo>
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<ForeName>Rishi J</ForeName>
<Initials>RJ</Initials>
<AffiliationInfo><Affiliation>Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hernandez-Diaz</LastName>
<ForeName>Sonia</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
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<Keyword MajorTopicYN="Y">malformations</Keyword>
<Keyword MajorTopicYN="Y">pregnancy</Keyword>
<Keyword MajorTopicYN="Y">rheumatic disorders</Keyword>
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