Is rupatadine safe in pregnancy?

Rupatadine Safety in Pregnancy

Rupatadine should be avoided during pregnancy, particularly in the first trimester, and should only be used if the benefits clearly outweigh potential risks after consultation with a healthcare professional. 1

Current Evidence and Recommendations

FDA and Regulatory Guidance

• The FDA drug label for rupatadine explicitly states to "ask a health professional before use" during pregnancy, indicating it lacks established safety data and requires medical consultation before any use 1

Guideline-Based Approach to Antihistamines in Pregnancy

General antihistamine principles:

• The British Journal of Dermatology guidelines recommend avoiding all antihistamines in pregnancy when possible, especially in the first trimester, though none has been proven teratogenic in humans 2
• When antihistamine treatment is absolutely necessary during pregnancy, chlorphenamine is often chosen in the UK due to its long safety record, while loratadine and cetirizine are FDA Pregnancy Category B drugs with more established safety profiles 2

Critical gap for rupatadine:

• Unlike loratadine and cetirizine, rupatadine lacks pregnancy category classification and has no published human pregnancy outcome data 1, 3
• The Journal of Allergy and Clinical Immunology published prospective data on 161 loratadine-exposed pregnancies showing no increased malformation risk 4, but no comparable data exists for rupatadine

Clinical Decision Algorithm

If antihistamine therapy is required during pregnancy:

1. First-line options - Use established antihistamines with documented safety records:

   • Chlorphenamine (long safety record) 2
   • Loratadine (FDA Category B, prospective human data available) 2, 4
   • Cetirizine (FDA Category B) 2

2. Alternative consideration - H2-blockers like famotidine (FDA Category B) can be considered safe options when antihistamine therapy is necessary 5

3. Avoid rupatadine - Switch to safer alternatives given:

   • No human pregnancy data available 1, 3
   • Lack of FDA pregnancy category classification 1
   • Availability of better-studied alternatives 2

Important Caveats

Timing considerations:

• The first trimester carries the highest teratogenic risk for all medications, making avoidance of poorly studied drugs like rupatadine particularly critical during this period 2

If inadvertent exposure occurs:

• Do not panic, as most antihistamines have not been proven teratogenic in humans 2
• Immediately consult with obstetrics and switch to a better-studied antihistamine 1
• Close monitoring is warranted given the lack of safety data 6

Risk-benefit assessment:

• While rupatadine has demonstrated good long-term safety in non-pregnant populations 7, this does not translate to pregnancy safety
• The principle that maternal benefit must outweigh potential fetal risk applies, but cannot be properly assessed without pregnancy-specific data 5