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

ICS Not Linked to Birth Defect Risk in Early Pregnancy, With Anick Bérard, PhD

First-trimester exposure to inhaled corticosteroid (ICS) monotherapy, montelukast, and combination therapies with long-acting beta agonists (LABA) did not show an increased risk of major congenital malformations compared with no

 medication use, according to new population-based data.

, Anick Bérard, PhD, from CHU Sainte-Justine, described these results as “reassuring.” She mentioned how many women with unexpected pregnancies may not find out that they are pregnant until 6 or 7 weeks later. However, this data shows that taking asthma medication during pregnancy is safe.

“The GINA guidelines say asthmatic women should be treated in pregnancy, and our study [with] a large cohort [is]… confirming what the guidelines are saying,” Bérard said. She noted that smaller datasets originally informed these guidelines, standing for Global Initiative for Asthma, whereas the current study provides confirmation using a substantially larger cohort.

Bérard and colleagues’ analysis included a large cohort of > 44,000 singleton births among women with asthma and compared multiple commonly used controller therapies during the first trimester. Regimens included montelukast, inhaled corticosteroids (ICS), ICS plus long-acting beta agonists (LABA), and montelukast plus ICS plus LABA combination.

She also cautioned that the study does not address all pregnancy outcomes, such as preterm birth or low birth weight, which require further investigation. Additionally, she noted that the cohort largely included women with private insurance, indicating a higher socioeconomic profile that may limit generalizability.

Overall, the data support ongoing use of ICS monotherapy and ICS/LABA combinations when clinically indicated.

“It's reassuring for prescribers, but also for pregnant women themselves, because we're all worried about major congenital malformation,” Bérard said. “The quality of life and health of the mother is as important as the health of the fetus, although in pregnancy, we prescribe for a maternal condition, but we don't always worry about the health of the mom. We worry about the health of the unborn child. Results like ours will put women at ease that they can, and they should be treated. It will have a beneficial impact on themselves, but it will not have an impact on their fetus, at least during the first trimester.”

Watch part 1 of our interview with Bérard here: 

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

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 cohort data showing no increased risk of major congenital malformations with ICS or ICS/LABA use in first trimester.

 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.”

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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