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Loratadine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Loratadine / pseudoephedrine is also known as: Alavert D-12 Hour Allergy and Sinus, AllerClear D-24 Hour, Allergy & Congestion Relief, Allergy Relief D 24 Hour, Allergy Relief D12, Claritin-D, Claritin-D 12 Hour, Claritin-D 24 Hour, Clear-Atadine-D, Leader Allergy Relief D-24, Loratadine-D 24 Hour

Loratadine / pseudoephedrine Pregnancy Warnings

Loratadine-pseudoephedrine has not been assigned to a pregnancy category by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Loratadine-pseudoephedrine is only recommended for use during pregnancy when benefit outweighs risk.

A case controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. The relative risk for other drugs was 1.6 for salicylates, 1.7 for acetaminophen, 1.3 for ibuprofen, and 1.5 for phenylpropanolamine (not significant). The authors hypothesized vascular disruption was the etiology of gastroschisis. A second group of 416 infants with heterogenous defects suspected to have a vascular etiology was studied. There was no increased risk associated with the use of salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine, and other decongestants. These data require independent confirmation. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine were recorded and 191 exposures any time during pregnancy. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980 to 1983 Medicaid data. Seven of the nine cases occurred in 3752 pseudoephedrine exposed pregnancies, providing a relative risk of 1.8. Only one case was a surgically treated abdominal wall defect (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The Collaborative Perinatal Project monitored 50,282 mother-child pairs. Only 39 first-trimester exposures to pseudoephedrine were recorded, with one birth defect observed. For use any time during pregnancy, 194 exposure were recorded with 3 birth defects observed (3.22 expected). The effect of pseudoephedrine on uterine and fetal blood flow was studied in 12 healthy pregnant women between 26 and 40 weeks gestation. Following a single 60 mg dose of pseudoephedrine, no significant effect was seen on fetal heart rate, uterine blood flow, or fetal aortic blood flow. There are no other data on the use of loratadine during pregnancy.

Loratadine / pseudoephedrine Breastfeeding Warnings

Loratadine concentration in human milk approximate that found in the serum of the mother. Approximately 0.029% of the administered dose is excreted in human milk. Pseudoephedrine is also excreted into human milk. Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached at 1 to 1.5 hours after dosing. In one woman, the milk:plasma concentration ratio at 1, 3, and 12 hours was 3.3, 3.9, and 2.6. The authors calculated that 1000 mL of breast milk consumed over 24 hours would provide an infant with 0.25 to 0.33 mg of pseudoephedrine or 0.5% to 0.7% of the dose ingested by the mother. There are no reports of adverse effects in infants who were exposed to pseudoephedrine by breast milk. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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