Fetal safety of loratadine use in the first trimester of pregnancy: A multicenter study

Background: Women in their childbearing years often require drug therapy for allergic conditions. Loratadine, a newer nonsedating antihistamine, is often used because of its preferred side effect profile. To date no published data exist on the safety of loratadine use in pregnancy. Objective: We sou...

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Bibliographic Details
Published in:	Journal of allergy and clinical immunology Vol. 111; no. 3; pp. 479 - 483
Main Authors:	Moretti, Myla E., Caprara, Daniela, Coutinho, Christopher J., Bar-Oz, Benjamin, Berkovitch, Mati, Addis, Antonio, Jovanovski, Elena, Schüler-Faccini, Lavínia, Koren, Gideon
Format:	Journal Article
Language:	English
Published:	New York, NY Mosby, Inc 01-03-2003 Elsevier Elsevier Limited
Subjects:	Abnormalities, Drug-Induced - epidemiology Adult Age allergy Anti-Allergic Agents - administration & dosage Anti-Allergic Agents - adverse effects Biological and medical sciences birth defect Birth weight Confidence intervals Control Groups Defects Dose-Response Relationship, Drug Drug Administration Schedule Drug dosages Drug toxicity and drugs side effects treatment Female Fetus - drug effects Hernias Humans Incidence Loratadine Loratadine - administration & dosage Loratadine - adverse effects Medical sciences Miscellaneous (drug allergy, mutagens, teratogens...) Patients Pharmacology. Drug treatments Pregnancy Pregnancy Trimester, First Safety Studies teratogens birth defect allergy teratogens pregnancy Loratadine TIS Human Immunopathology Allergy Antihistaminic Pregnancy Chemotherapy Treatment Female Antagonist Teratogen H1 Histamine receptor
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Summary:	Background: Women in their childbearing years often require drug therapy for allergic conditions. Loratadine, a newer nonsedating antihistamine, is often used because of its preferred side effect profile. To date no published data exist on the safety of loratadine use in pregnancy. Objective: We sought to determine whether the use of loratadine in the first trimester of pregnancy was associated with an increased risk for major malformations. Secondary outcomes included rates of miscarriage, birth weights, and gestational age at delivery. Methods: All women were prospectively enrolled from 4 participating centers. Detailed maternal medical history and drug exposures were collected at intake, whereas pregnancy complications and outcomes were collected at follow-up. A group of unexposed control subjects were recruited and followed up in a similar manner. Results: This report includes follow-up on 161 loratadine exposed pregnancies and an equal number of unexposed control subjects. Maternal characteristics (age, pregnancy history, alcohol consumption, and smoking habits) were not different between the 2 groups. There were 5 malformations observed in the exposed group and 6 in the control group, which was not significantly different (P = .9) Similarly, the live birth rate, gestational age at delivery, and birth weights were not different between the 2 groups. Conclusion: These results suggest that loratadine use in pregnancy is not associated with a large risk for major malformations. Further studies are warranted to confirm these findings and to increase study power. (J Allergy Clin Immunol 2003;111:479-83.)
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	0091-6749 1097-6825
DOI:	10.1067/mai.2003.130