Safety of Montair LC (Montelukast and Levocetirizine) During Pregnancy
Montair LC should be avoided during pregnancy for chronic rhinosinusitis (CRS) management, though montelukast alone may be considered for recalcitrant asthma if the patient has shown a favorable response prior to pregnancy. 1
Montelukast Safety in Pregnancy
- Montelukast is classified as FDA Pregnancy Category B, indicating that animal studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women 2
- No teratogenicity was observed in animal studies at doses up to 100 times the maximum recommended human dose 2
- Expert panel recommendations suggest avoiding anti-leukotrienes for CRS maintenance during pregnancy, but montelukast can be continued/initiated for recalcitrant asthma during pregnancy, especially in those with prior response 1
- Montelukast crosses the placenta following oral dosing in animal studies 2
- The manufacturer maintains a registry to monitor pregnancy outcomes of women exposed to montelukast during pregnancy 2
Recent Evidence on Montelukast in Pregnancy
- A 2016 Japanese prospective cohort study found that montelukast was not associated with increased risk of major congenital anomalies (adjusted odds ratio 0.78; 95% CI 0.23-2.05) 3
- A 2017 Danish population-based study found no significant increase in the risk of major congenital anomalies with montelukast exposure (adjusted odds ratio 1.4; 95% CI 0.9-2.3), though there was an increased risk of preterm birth and maternal complications likely associated with underlying maternal asthma 4
- A 2009 multicenter prospective comparative study showed that montelukast did not appear to increase the baseline rate of major malformations, though birth weight was lower in the montelukast group 5
Levocetirizine Safety in Pregnancy
- Antihistamines should be used with caution during pregnancy 1
- First-generation antihistamines should be avoided given their sedative and anticholinergic properties 1
- Limited data are available on the safety of levocetirizine specifically during pregnancy 1
- For allergic rhinitis management during pregnancy, second-generation antihistamines are generally preferred over first-generation ones due to their better safety profile 1
Combination Therapy Considerations
- The safety of the combination of montelukast and levocetirizine (Montair LC) has not been specifically studied in pregnancy
- When considering medication use during pregnancy, the clinician should compare the benefits and risks of each medication, balancing maternal risk of therapy versus no therapy and the fetal risk of uncontrolled maternal disease with the risk of therapy on the newborn 1
- For CRS management during pregnancy, saline nasal rinses and topical corticosteroid nasal sprays are likely more suitable maintenance therapy options 1
Recommendations for Clinical Practice
For rhinosinusitis management during pregnancy:
If asthma management is required:
- Montelukast alone may be considered for recalcitrant asthma if the patient has shown a favorable response prior to pregnancy 1
- Inhaled medications have been used for many years without documentation of adverse effects on the fetus 1
- Untreated asthma resulting in severe exacerbation with maternal hypoxia has well-described adverse effects on the fetus 1
For allergic rhinitis management:
Important Caveats
- If a woman becomes pregnant while taking Montair LC, discuss the risks and benefits of continuing therapy versus switching to safer alternatives
- Healthcare providers are encouraged to report any prenatal exposure to montelukast to the manufacturer's Pregnancy Registry 2
- The combination of montelukast and levocetirizine has not been specifically studied in pregnancy, making individual components' safety profiles the basis for decision-making
- Always prioritize medications with established safety records during pregnancy when treating respiratory conditions