Is Ebastel (ebastine) safe to use during pregnancy?

Ebastine Use During Pregnancy

Ebastine should be avoided during pregnancy due to insufficient safety data and the availability of better-studied antihistamine alternatives.

Safety Classification and Available Evidence

Ebastine is a second-generation antihistamine used for allergic rhinitis and chronic urticaria. However, there is limited information about its safety during pregnancy:

• No specific FDA pregnancy category has been assigned to ebastine in the provided guidelines
• There are insufficient human pregnancy safety data for ebastine compared to other antihistamines 1
• The 2008 rhinitis practice parameter specifically notes "limited data on desloratadine, azelastine, and levocetirizine" but does not mention ebastine among antihistamines with established pregnancy safety profiles 1

Antihistamine Use During Pregnancy

When antihistamines are needed during pregnancy, guidelines recommend:

• First-generation antihistamines like chlorpheniramine have extensive safety data from long-term use, though they have sedative effects 1
• Second-generation antihistamines with more established pregnancy safety data should be preferred over those with limited data 1
• The safety of antihistamines during pregnancy has been confirmed through large birth registries, case-control studies, and cohort studies 1

Preferred Antihistamine Options During Pregnancy

If antihistamine treatment is necessary during pregnancy, the following options have better safety documentation:

• Chlorpheniramine (first-generation) has extensive safety data 1
• Loratadine and cetirizine (second-generation) have more accumulated pregnancy safety data than ebastine 1, 2

Important Considerations

• The most critical time for potential congenital malformations is the first trimester during organogenesis 1
• All medication use during pregnancy should prioritize the lowest effective dose 1
• Risk-benefit assessment is essential before prescribing any medication during pregnancy 2

Cautions and Contraindications

• Diphenhydramine, while frequently used during pregnancy, has been associated with cleft palate development in some studies 1
• Hydroxyzine should be used cautiously during the first trimester based on animal data 1
• Oral decongestants should be avoided during the first trimester due to possible associations with congenital malformations 1

Alternative Management Options

For allergic rhinitis during pregnancy, safer treatment options include:

1. Intranasal corticosteroids (particularly budesonide, which is FDA Pregnancy Category B) 1
2. Sodium cromolyn (FDA Pregnancy Category B) 1
3. Well-studied antihistamines with established safety profiles 1

Remember that the absence of safety data does not mean a medication is safe during pregnancy. When treating allergic conditions during pregnancy, it is prudent to select medications with established safety profiles rather than those with limited pregnancy data like ebastine.