Is levocetirizine (Xyzal) safe to use during pregnancy?

Levocetirizine Use in Pregnancy

Levocetirizine has limited safety data in pregnancy and should not be used as a first-line antihistamine; instead, choose cetirizine or loratadine, which have extensive human safety data demonstrating no increased risk of congenital malformations. 1, 2

Why Not Levocetirizine as First Choice

• Limited pregnancy data exists for levocetirizine, making it a less desirable option compared to its parent compound cetirizine 1
• The FDA label for levocetirizine specifically states to "ask a health professional before use" if pregnant, reflecting the lack of robust safety data 3
• Guidelines explicitly note that "currently, there are also limited data on desloratadine, azelastine, and levocetirizine" 1

Preferred Antihistamine Options During Pregnancy

Use cetirizine or loratadine as first-line second-generation antihistamines, as these are the most well-studied agents in pregnancy with reassuring safety profiles 2, 4:

• Cetirizine is recommended by the American College of Obstetricians and Gynecologists as a preferred second-generation antihistamine based on extensive safety data 2
• Large birth registries, case-control studies, and cohort studies confirm the safety of second-generation antihistamines like cetirizine during the first trimester 1
• A manufacturer safety database study of 228 cetirizine-exposed pregnancies showed 83.7% resulted in live births with only 2 congenital malformations (consistent with background rates) 5
• Both cetirizine and loratadine are FDA Pregnancy Category B drugs with long safety records 4

Clinical Approach Algorithm

Step 1: Start with non-pharmacologic measures first 2:

• Saline nasal rinses
• Allergen avoidance

Step 2: If medication needed, use cetirizine or loratadine 2, 4:

• These have the most extensive human pregnancy data
• Benefits of symptom control outweigh theoretical risks for moderate to severe allergic rhinitis 2

Step 3: For severe symptoms, combine with intranasal corticosteroids 2:

• Budesonide has strong safety data in pregnancy
• This combination is more effective than antihistamines alone

Critical Timing Considerations

• The first trimester is the most critical period when organogenesis occurs and medication-related congenital malformations are most likely 1
• However, second-generation antihistamines in general do not show a significant increase in congenital malformations when used during the first trimester 1

Common Pitfalls to Avoid

• Avoid first-generation antihistamines due to sedative and anticholinergic properties, and some associations with congenital malformations 2
• Do not use oral decongestants during the first trimester due to conflicting reports of associations with gastroschisis and small intestinal atresia 1
• Avoid diphenhydramine if possible due to lingering concerns about cleft palate association 1

If Levocetirizine Must Be Considered

If a patient has had a uniquely favorable response to levocetirizine before pregnancy and other options have failed:

• Discuss the limited safety data with the patient 1
• Use shared decision-making to weigh benefits versus theoretical risks 1
• Consider switching to cetirizine (the racemic mixture) as it contains levocetirizine and has extensive safety data 5