Anick Bérard PhD, a researcher at CHU Sainte-Justine in Montreal, professor at the University of Montreal, and an adjunct professor Université Claude Bernard Lyon 1.

Anick Bérard PhD

Asthma Controllers Safe in First Trimester, With Anick Bérard, PhD

 controller medications was not associated with an increased risk of major congenital malformations, according to new population-based cohort data discussed by Anick Bérard, PhD, from CHU Sainte-Justine.

“This is reassuring for those who actually prescribe to pregnant women with asthma some medications,” Bérard said. “It’s also reassuring for the mom who wonders whether she needs to stop her medications or continue.”

In their population-based cohort study, Bérard and colleagues sought to assess the association between first-trimester use of 5 common asthma controller regimens and the risk of major congenital malformations in the offspring of women with asthma. Investigators included 44,435 singleton live births to mothers with asthma from the 2003 to 2021 AM-PREGNANT cohort (American Pregnancy-Mother-Child Cohort) and compared outcomes across 5 controller regimens: montelukast, inhaled corticosteroids (ICS), montelukast plus ICS combination, ICS plus long-acting beta agonists (LABA), and montelukast plus ICS plus LABA combination. Medication exposure was based on first-semester prescription fills.

Across groups, first-trimester exposure to these medications was not linked to an increased risk of major congenital malformations compared with no controller medication use. Bérard noted the results align with longstanding Global Initiative for Asthma (GINA) guideline recommendations but add strength through a substantially larger cohort.

The analysis also addressed concerns surrounding montelukast use following a 2020 boxed warning related to neuropsychiatric events in adolescents. Bérard said the warning contributed to reduced prescribing during pregnancy despite limited pregnancy-specific safety data. By including nearly 3000 pregnant individuals exposed to montelukast, the study provided one of the largest evaluations of this medication in pregnancy to date. The absence of an increased malformation risk in this larger sample helps clarify prior uncertainty from smaller studies.

Investigators additionally compared monotherapy and combination regimens. Bérard reported no meaningful differences across various regimens. These findings support the relative safety of maintaining controller therapy when clinically indicated.

A potential signal emerged for cleft palate or cleft lip among individuals receiving montelukast plus ICS, although event numbers were < 5. Bérard emphasized caution in interpreting this observation, noting the rarity of the outcome.

“You have to remember that the baseline prevalence of cleft lip, cleft palate in the general pregnant population is quite low, less than 1%, so even if we've seen a very small increase in risk, it remains very rare,” Bérard said. “You always balance the risk with the benefit of using the medication, and in our study, we didn't look at benefits at all. We just looked at [the] risk of malformation. Just keep in mind [this study] needs to be replicated [with a] larger sample size.”

Jiao XF, Leal LF, Ducharme FM, Tse SM, Bérard A. First-trimester asthma controller medication use and major congenital malformation risk in offspring of women with asthma: A nationwide population-based cohort study. 

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In an interview, Bérard discusses population-based data showing no increased risk of major congenital malformations with first-trimester asthma controller use.

Anick Bérard PhD

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