Maternal Exposure to HCQ Not Linked To Structural Birth Defects

Previous small studies have shown the pregnancy safety of hydroxychloroquine. However, a recent report found an increase in major birth defects at doses ≥400 mg/day. "We often have insufficient information about pregnancy safety even when the medication has been in use for many years", said Dr Christina D. Chambers in an interview. Therefore, Dr Christina D. Chambers and her team conducted a study to examine pregnancy outcomes following the use of hydroxychloroquine.

MotherToBaby prospective pregnancy studies are conducted by the Organization of Teratology Information Specialists participants from throughout the United States and Canada. For this study, Christina and her team included 837 participants data from MotherToBaby prospective pregnancy studies. Among these patients, 279 received hydroxychloroquine, 279 were disease-matched individuals who were unexposed to hydroxychloroquine, and 279 were healthy comparators. The researchers evaluated the data collected through interviews, medical records, and dysmorphology examinations. Outcomes assessed were major and minor birth defects, spontaneous abortion, preterm delivery and infant growth.

Key findings of the study:

• Among 837 participants, pregnancies (7.2%) were lost-to-follow-up.
• Among live births, the researchers found that 8.6% with first-trimester hydroxychloroquine exposure had a major birth defect compared to 7.4% in the disease-matched group (Odds Ratio (OR) 1.18), and 5.4% in the healthy group (adjusted OR 0.76).
• They further noted that the risks did not differ at doses ≥400 mg/day.
• They observed no pattern of birth defects and no differences in the rates of spontaneous abortion or preterm delivery.
• They found that the growth deficiency measures did not differ in the hydroxychloroquine-exposed vs disease-matched group, except birth head circumference (adjusted OR 1.85).

The authors concluded, "We found no evidence of an increased risk for structural defects or other outcomes with hydroxychloroquine, with the exception of birth head circumference. For women treated with hydroxychloroquine, these findings are reassuring."

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DOI: https://doi.org/10.1002/art.42015