Hydroxychloroquine early in pregnancy and risk of birth defects

Huybrechts, Krista F.; Bateman, Brian T.; Zhu, Yanmin; Straub, Loreen; Mogun, Helen; Kim, Seo Young; Desai, Rishi; Hernández–Dı́az, Sonia

doi:10.1016/j.ajog.2020.09.007

Cited by 72 publications

(62 citation statements)

References 35 publications

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“…Among women with rheumatic diseases, medication use, including HCQ, during pregnancy is recommended to decrease the occurrence of flares, as disease flares have been associated with poorer pregnancy outcomes (Clowse et al, 2006 ; Götestam Skorpen et al, 2016 ; Leroux et al, 2015 ). A recent study by Huybrechts et al ( 2020 ) presented a summary of existing literature surrounding HCQ and the risk of birth defects, noting that these studies have been small case series, small cohort studies of exposed pregnancies, and studies without controls. The authors used two large US claims databases to explore HCQ use and the risk of birth defects among 2,045 HCQ‐exposed and 3,198,589 unexposed pregnancies.…”

Section: Discussionmentioning

confidence: 99%

“…However, concerns about its safety in pregnancy exist given that HCQ crosses the placenta and data on the risks of birth defects associated with HCQ use are sparse (Costedoat‐Chalumeau et al, 2002 ). Though most existing studies have not identified specific signals for safety concerns, a recent cohort study using data from two pharmaceutical claims databases reported an increased risk for any birth defect among women filling prescriptions for HCQ with a daily dose ≥400 mg (Huybrechts et al, 2020 ). While unable to explore the risk of specific birth defects due to the small number of exposed cases, the authors found associations with large groupings of birth defects, including birth defects in the respiratory and urinary tract systems, and oral clefts (Huybrechts et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

“…Though most existing studies have not identified specific signals for safety concerns, a recent cohort study using data from two pharmaceutical claims databases reported an increased risk for any birth defect among women filling prescriptions for HCQ with a daily dose ≥400 mg (Huybrechts et al, 2020 ). While unable to explore the risk of specific birth defects due to the small number of exposed cases, the authors found associations with large groupings of birth defects, including birth defects in the respiratory and urinary tract systems, and oral clefts (Huybrechts et al, 2020 ). We sought to describe all women who reported HCQ use in pregnancy and describe the presence of specific major birth defects in their offspring within two multi‐site, case–control studies of birth defects, the National Birth Defects Prevention Study (NBDPS) and the Slone Epidemiology Center Birth Defects Study (BDS).…”

Section: Introductionmentioning

confidence: 99%

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Maternal exposure to hydroxychloroquine and birth defects

Howley

Werler

Fisher

et al. 2021

Birth Defects Research

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Background Hydroxychloroquine is a treatment for rheumatic disease and considered safe during pregnancy. Interest in hydroxychloroquine has increased as it is being examined as a potential treatment and prophylaxis for coronavirus disease 2019. Data on the risks of specific birth defects associated with hydroxychloroquine use are sparse. Methods Using data from two case–control studies (National Birth Defects Prevention Study and Slone Epidemiology Center Birth Defects Study), we described women who reported hydroxychloroquine use in pregnancy and the presence of specific major birth defects in their offspring. Cases had at least one major birth defect and controls were live‐born healthy infants. Women self‐reported medication use information in the few months before pregnancy through delivery. Results In total, 0.06% (19/31,468) of case and 0.04% (5/11,614) of control mothers in National Birth Defects Prevention Study, and 0.04% (11/29,838) of case and 0.05% (7/12,868) of control mothers in Birth Defects Study reported hydroxychloroquine use. Hydroxychloroquine users had complicated medical histories and frequent medication use for a variety of conditions. The observed birth defects among women taking hydroxychloroquine were varied and included nine oral cleft cases; the elevated observed:expected ratios for specific oral cleft phenotypes and for oral clefts overall had 95% confidence intervals that included 1.0. Conclusion While teratogens typically produce a specific pattern of birth defects, the observed birth defects among the hydroxychloroquine‐exposed women did not present a clear pattern, suggesting no meaningful evidence for the risk of specific birth defects. The number of exposed cases is small; results should be interpreted cautiously.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Maternal exposure to hydroxychloroquine and birth defects

Howley

Werler

Fisher

et al. 2021

Birth Defects Research

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“…Hence, we are reporting this rare case of bilateral clubfoot in RA's mother. 17 Ventricular septal defects and coarctation of the aorta have been described in babies born to mothers who have received sulfasalazine during pregnancy. However, musculoskeletal abnormalities have not yet been reported as their teratogenicity.…”

Section: Discussionmentioning

confidence: 99%

Bilateral idiopathic club foot in baby of a rheumatoid mother: A rare case report and its management

Agrawal¹,

Inamdar²,

Choudhary³

et al. 2021

IJOR

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Congenital clubfoot has a multifaceted etiology, with several hypotheses offered in its etiopathogenesis. The clubfoot has rarely been reported in babies born to women who have rheumatoid arthritis (RA). We present a rare case of a 31-year-old lady with RA on disease-modifying anti-rheumatoid drugs who delivered a child with bilateral congenital clubfoot. She had previously been using Methotrexate, Hydroxychloroquine, and Sulfasalazine regularly, but Methotrexate was stopped seven months before pregnancy. A full-term female baby was born through the cesarean section with bilateral clubfoot deformity and a modified Pirani score of eight out of 10. The deformity correction was done with the Ponseti serial casting method. The final modified Pirani score was two out of ten. In newborns born to rheumatoid arthritis mothers, the club foot deformity was effectively treated with serial Ponseti corrective casts, as was idiopathic clubfoot in babies born to non-rheumatoid mothers. Our findings validate the Ponseti serial casting method for these kinds of patients.

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“…Huybrechts et al reports quantified the risk of congenital malformations/birth defects related to early pregnancy administered with hydroxychloroquine and its potential use as prophylaxis were notable [76].…”

Section: Hydroxychloroquinementioning

confidence: 99%

COVID-19 and pregnant women – An overview on diagnosis, treatment approach with limitation, and clinical management

Pattanashetti

Patil

Nyamgouda

et al. 2021

Monaldi Arch Chest Dis

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Coronavirus disease or more popularly called COVID-19 is known to be caused by a novel coronavirus 2. The COVID-19 has been identified to be originated from Wuhan, Hubei, China. This pandemic started in December 2019, and since then it has spread across the world within a short period. The health and family welfare ministry of the Government of India reported 227,546 active, 9,997,272 discharged cases, and 150,114 deaths due to COVID-19 as of 06 January 2021. Indian Council of Medical Research (ICMR) reports that the cumulative testing status of SARS-CoV-2 (COVID-19) was 931,408 up to November 03, 2020. Currently, no specific anti-viral drug for COVID-19 management is recommended in the current scenario. Vulnerable populations such as pregnant women affected by COVID-19 infection need to be recognized and followed up for effective handling concerning morbidity and mortality. At present, very few case reports on COVID-19 infected pregnant women have been published in India and there is no proven exclusive treatment protocol. This article summarizes a review of signs and symptoms, etiopathogenesis, risk factors, diagnosis, and possible management of COVID-19 infection in pregnant women. This overview may be useful for health care providers for practical approach and limitation of drugs used in the current management and considers the choice of drugs with their special attention given to adverse effects to improvise maternal health, pregnancy, and birth outcomes.

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Hydroxychloroquine early in pregnancy and risk of birth defects

Cited by 72 publications

References 35 publications

Maternal exposure to hydroxychloroquine and birth defects

Maternal exposure to hydroxychloroquine and birth defects

Bilateral idiopathic club foot in baby of a rheumatoid mother: A rare case report and its management

COVID-19 and pregnant women – An overview on diagnosis, treatment approach with limitation, and clinical management

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