Fetal Safety Profile of Fexofenadine (Allegra) During Pregnancy Interview with:
Niklas Andersson MS

Department of Epidemiology Research
Statens Serum Institut
Copenhagen S, Denmark What is the background for this study? What are the main findings?

Response: Second-generation antihistamines are among the most commonly prescribed drug classes during pregnancy. Fexofenadine is a widely used antihistamine but given the limited fetal safety on the use of antihistamines during pregnancy in general, current clinical guidelines only recommend the use cetirizine and loratadine during pregnancy when needed due to a larger body of fetal safety data for these antihistamines. What are the main findings?

ResponseThis nationwide cohort study found no association between use of fexofenadine during pregnancy and the risk of adverse fetal outcomes which included major birth defects, spontaneous abortion, preterm birth, small size for gestational age, and stillbirth while comparing with pregnancies with use of cetirizine. Additional analyses, comparing to other pregnancy groups such as pregnancies with use of loratadine, showed similar results. What should readers take away from your report?

Response: Previous literature regarding the potential fetal risk associated with the use of fexofenadine during pregnancy is very limited. Our study provides fetal safety data on a large number of exposed pregnancies (up to 6153 pregnancies included, depending on the specific outcome analysis) suggesting that the fetal safety profile of fexofenadine is comparable to those currently recommended second-generation antihistamines during pregnancy. What recommendations do you have for future research as a result of this study?

Response: While we believe these results may help inform patients, clinicians, and drug regulatory agencies regarding the fetal safety of fexofenadine use during pregnancy; given the previous limited body of data, our findings should be replicated in other independent populations. Is there anything else you would like to add? Any disclosures?

Response: As randomized trials are unlikely to be conducted to inform on the issue, carefully designed observational studies are needed to evaluate on this issue.


Andersson NW, Torp-Pedersen C, Andersen JT. Association Between Fexofenadine Use During Pregnancy and Fetal Outcomes. JAMA Pediatr. Published online June 01, 2020. doi:10.1001/jamapediatrics.2020.1316

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