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Use of leukotriene-receptor antagonists (LTRAs) during pregnancy was not associated with significant risks of neuropsychiatric events in offspring, according to a nationwide cohort study from Taiwan.

Among the children of women with a diagnosis of asthma or allergic rhinitis during pregnancy, no significant associations were found between prenatal LTRA exposure and attention deficit-hyperactivity disorder (ADHD; adjusted HR 1.03, 95% CI 0.79-1.35), autism spectrum disorder (ASD; aHR 1.01, 95% CI 0.65-1.59), and Tourette syndrome (aHR 0.63, 95% CI 0.29-1.36), reported Tsung-Chieh Yao, MD, PhD, of Chang Gung University College of Medicine in Taoyuan, and co-authors.

In addition, duration of LTRA use (1-4 weeks vs >4 weeks) and cumulative dose of LTRA (1-170 mg vs >170 mg) were not significantly associated with ADHD, ASD, or Tourette syndrome among children, they noted in a research letter published in .

"Over the years, the U.S. Food and Drug Administration has monitored postmarketing data about the potential harm of neuropsychiatric events (NEs) associated with montelukast [Singulair], the first type of LTRAs, and issued boxed warnings about serious NEs associated with montelukast use in 2020," Yao and team wrote. "However, evidence regarding the risk of NEs associated with LTRAs has been conflicting."

The boxed warning expanded on warnings about these events that were included on the drug's label since 2008 after of "agitation, depression, sleeping problems, and suicidal thoughts and actions."

At the time, Sally Seymour, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products at the FDA's Center for Drug Evaluation and Research said in that "the incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and healthcare professionals are not fully aware of these risks."

Yao and colleagues concluded that "clinicians prescribing LTRAs to pregnant women with asthma or allergic rhinitis may be reassured by our findings of no increased risk of NEs in offspring," though they noted that their "findings should be confirmed by further replication studies."

For this study, Yao and team used data from the National Health Insurance Research Database to identify a total of 576,157 maternal-child pairs from 2009 to 2019 in Taiwan. After propensity score matching, 1,988 children exposed to LTRAs (mean age 4.25 years) and 19,863 non-exposed children (mean 4.28 years) were included in the subsequent analyses.

Mothers who had multiple births or a child with congenital malformations were excluded.

Among both LTRA users and non-users, over 60% were 30 to 40 years old at delivery.

Of the children whose mothers used LTRAs during pregnancy, 3.31% were diagnosed with ASD, 1.25% were diagnosed with ADHD, and 0.45% were diagnosed with Tourette syndrome.

Yao and colleagues noted that their study had a nonrandomized design, which was a limitation. They were also unable to detect neuropsychiatric events risks beyond the first several years of life. Furthermore, the results may not be generalizable to non-Asian populations.

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