Maternal exposure to hydroxychloroquine and birth defects

Howley, Meredith M.; Werler, Martha M.; Fisher, Sarah C.; Zutphen, Alissa R. Van; Carmichael, Suzan L.; Broussard, Cheryl S.; Heinke, Dominique; Ailes, Elizabeth C.; Pruitt, Shannon; Reefhuis, Jennita; Mitchell, Allen A.; Browne, Marilyn L.

doi:10.1002/bdr2.1943

Cited by 8 publications

(2 citation statements)

References 42 publications

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“…With regards to safety of HCQ in pregnancy, studies from the literature have suggested no hydroxychloroquine-related adverse effects on the fetus [ 20 , 50 , 61 , 62 , 63 , 64 , 65 ], with the exception of one meta-analysis that showed an increased rate of spontaneous pregnancy when HCQ was administered in the first weeks of pregnancy [ 66 ]. However, underlying conditions were not excluded when doing the meta-analysis, and therefore the result was potentially biased and thus further research is needed to provide accurate information.…”

Section: Results and Discussion: Hydroxychloroquine In Pregnancymentioning

confidence: 99%

The Potential Benefit of Hydroxychloroquine in Chronic Placental Inflammation of Unknown Etiology Associated with Adverse Pregnancy Outcomes

et al. 2022

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The placenta is the site of connection between maternal and fetal circulation, and the liaison is established early in pregnancy. A large variety of pregnancy complications such as preterm birth, fetal growth restriction, or pregnancy loss have placental expression and can be accompanied in some cases of acute or chronic identifiable placental inflamatory lesions. Chronic placental inflammatory (CPI) lesions include chronic villitis of unknow etiology (CVUE), chronic intervillositis of unknown etiology, CIUE (also described as chronic histiocytic intervillositis, CHI), and chronic deciduits. Hydroxychloroquine (HCQ) has been prescribed with good results during pregnancy to prevent adverse perinatal outcomes in maternal autoimmune conditions. Its success has paved the way to its use in CPI as CIUE/CHI; however, to date, there are no prospective, informatively designed, controlled studies on its value in these setting. This review aims to explore the potential role of HCQ in CPI of unknown etiology. Ideally, properly designed, probably multicentric studies should be undertaken to fully understand HCQ’s role for prevention of adverse pregnancy outcomes after a chronic placental inflammation.

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Section: Results and Discussion: Hydroxychloroquine In Pregnancymentioning

confidence: 99%

The Potential Benefit of Hydroxychloroquine in Chronic Placental Inflammation of Unknown Etiology Associated with Adverse Pregnancy Outcomes

et al. 2022

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“…First, the sample size available for this analysis was insufficiently powered to rule out elevated risks for most specific individual major birth defects. However, specific patterns of major structural birth defects are characteristic of known human teratogens (28). Therefore, it is reassuring that no such pattern was identified in this study.…”

Section: Discussionmentioning

confidence: 99%

Birth Outcomes in Women Who Have Taken Hydroxycholoroquine During Pregnancy: A Prospective Cohort Study

Chambers

Johnson

et al. 2022

Arthritis & Rheumatology

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Objective Findings from previous small studies have been reassuring regarding the safety of treatment with hydroxychloroquine (HCQ) during pregnancy. In one recent study, it was demonstrated that the frequency of major birth defects was increased in women who had received HCQ at a dose of ≥400 mg/day during pregnancy. This study was undertaken to examine pregnancy outcomes among women following the use of HCQ. Methods The study cohort comprised pregnant women who were prospectively enrolled in the MotherToBaby/Organization of Teratology Information Specialists Autoimmune Diseases in Pregnancy Study and were receiving treatment with HCQ. For the control groups, disease‐matched women without HCQ exposure and healthy women were randomly selected from the same source, with subject matching using a 1:1 ratio. Data were collected through interviews, medical records, and dysmorphology examinations. Pregnancy outcome measures included the presence or absence of major and minor birth defects, rates of spontaneous abortion, rates of preterm delivery, and infant growth measures. Results Between 2004 and 2018, 837 pregnant women met the criteria for study inclusion, including 279 women exposed to HCQ during pregnancy and 279 women in each unexposed control group. Sixty pregnant women (7.2%) were lost to follow‐up. Among the women with live births, major birth defects occurred as a pregnancy outcome in 20 (8.6%) of 232 women with HCQ exposure in the first trimester, compared to 19 (7.4%) of 256 disease‐matched unexposed controls (odds ratio [OR] 1.18, 95% confidence interval [95% CI] 0.61–2.26) and 13 (5.4%) of 239 healthy controls (adjusted OR 0.76, 95% CI 0.28–2.05). Risks did not differ in women who were receiving an HCQ dose of ≥400 mg/day. No pattern of birth defects was identified. There were no differences in the rates of spontaneous abortion or preterm delivery between groups. Occurrence of infant growth deficiencies did not differ in the HCQ‐exposed group compared to the disease‐matched unexposed control group, except in the infant's head circumference at birth (adjusted OR 1.85, 95% CI 1.07–3.20). Conclusion In this study, there was no evidence of an increased risk of structural birth defects or other adverse outcomes among women receiving HCQ during pregnancy, with the exception of infant head circumference at birth. For pregnant women being treated with HCQ, these findings are reassuring.

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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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Maternal exposure to hydroxychloroquine and birth defects

Cited by 8 publications

References 42 publications

The Potential Benefit of Hydroxychloroquine in Chronic Placental Inflammation of Unknown Etiology Associated with Adverse Pregnancy Outcomes

The Potential Benefit of Hydroxychloroquine in Chronic Placental Inflammation of Unknown Etiology Associated with Adverse Pregnancy Outcomes

Birth Outcomes in Women Who Have Taken Hydroxycholoroquine During Pregnancy: A Prospective Cohort Study

Maternal exposure to hydroxychloroquine and birth defects

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