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
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 .
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) . 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 .
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 .
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
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
different between the 2 groups .
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 
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.
The American Academy of Pediatrics has classified loratadine as a drug "Usually Compatible With Breastfeeding"
1.Claritin TSR package insert.
http://www.fda.gov/cder/pediatric/labels/Lorat.pdf (PDF file)
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.
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.
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.
8.Hilbert J, et al. Excretion of loratadine in human breast milk.
J Clin Pharmacol. 1988;28:234-9. MEDLINE
Transfer of drugs and other chemicals into human milk. Pediatrics. 2001