Loratadine in Pregnancy and Breastfeeding
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Loratadine (Claritin )
Anihistamine. Molecular weight:382.89

There was no evidence of animal teratogenicity in studies performed in rats and rabbits at oral doses up to 96 mg/kg (approximately 75 times and 150 times, respectively, the maximum recommended human daily oral dose on a mg/m2 basis) [1].

In an observational study of newly marketed drugs prescribed in England loratadine was taken during the first trimester in 18 pregnancies. Two patients chose to have an elective abortion. The remaining mothers delivered 16 normal term infants [2].

Kallen B et al. reported fifteen cases of hypospadias among 2780 children of women who had taken loratadine during pregnancy in the Swedish Birth Registry (5.6 expected) [3]. However, data from the National Birth Defects Prevention Study (NBDPS) found no increased risk for second- or third-degree hypospadias among women who used loratadine in early pregnancy [4].

Diav-Citrin O, et al. found no increase in the rate of major anomalies in the infants of 126  women who had  used loratadine during first trimester when compared to nonexposed controls [5].

In addition, a prospective study using data from four countries compared the outcomes of 161 loratadine exposed pregnancies with the outcomes of an equal number of unexposed control subjects. All patients were exposed at least during the first trimester (13 weeks) of pregnancy. Among the loratadine exposed cohort there were 140 live births, 18 spontaneous abortions, 3 elective abortions, and 1 fetal death. Data included 1 set of twins in each group. Exposure to loratadine did not appear to significantly increase the rate of major malformations above that found amongst unexposed controls. The live birth rate, gestational age at delivery, and birth weights were also not different between the 2 groups [6].

The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI) recommend chlorpheniramine and tripelennamine as the antihistamines of choice for pregnant women.  Cetirizine and loratadine may be considered (preferably after the first trimester) in patients who cannot tolerate or do not respond to maximal doses of chlorpheniramine or tripelennamine [7]

BREAST FEEDING:  Loratadine and its metabolite, descarboethoxyloratadine, are excreted into human milk . The AUCmilk/AUCplasma ratio for loratadine and descarboethoxyloratadine were  1.17 and 0.85 respectively in 6 lactating women after ingestion of a single 40 mg dose of  loratadine. The peak milk concentration, 29.2 ng/mL, occurred within 2 hours of the dose. A 4-kg infant ingesting the loratadine and descarboethoxyloratadine excreted would have received a dose equivalent to 0.46% of the loratadine dose received by the mother on a mg/kg basis[8].

The American Academy of Pediatrics has classified loratadine as a drug "Usually Compatible With Breastfeeding" [9].


1.Claritin TSR package insert. http://www.fda.gov/cder/pediatric/labels/Lorat.pdf (PDF file)
Accessed 4/7/04
2. Wilton LV, Pearce GL, Martin RM, et al.: The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 105:882- 889, 1998. MEDLINE
3. Kallen B, Otterblad Olausson P. Monitoring of maternal drug use and infant congenital malformations: does loratadine cause hypospadias? Int J Risk Safety Med 2001;14:115-9
4. Evaluation of an association between loratadine and hypospadias--United States, 1997-2001.MMWR Morb Mortal Wkly Rep. 2004 19;53:219-21. MEDLINE
5. Diav-Citrin O, et al. Pregnancy outcome after gestational exposure to loratadine or antihistamines: a prospective controlled cohort study.J Allergy Clin Immunol. 2003; 111: 1239-43.MEDLINE
6. Moretti ME, et al. Fetal safety of loratadine use in the first trimester of pregnancy: a multicenter study. J Allergy Clin Immunol. 2003;111:479-83. MEDLINE
7. The use of newer asthma and allergy medications during pregnancy. Position Statement. The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI). Ann Allergy Asthma Immunol. 2000;84:475-480. MEDLINE
8.Hilbert J, et al. Excretion of loratadine in human breast milk.
J Clin Pharmacol. 1988;28:234-9. MEDLINE
9. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Review.

Created: 4/7/2004
Updated: 4/7/2004

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