Azatadine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brand names: Trinalin Repetabs

Azatadine / pseudoephedrine Pregnancy Warnings

Azatadine-pseudoephedrine has been assigned to pregnancy category C by the FDA. Animal studies using doses 5 to 12 times those normally used in humans have revealed evidence of adverse fetal outcome. There are no controlled data in human pregnancy. Azatadine-pseudoephedrine is only recommended for use during pregnancy benefit outweighs risk.

Azatadine:

In a review of 229,101 deliveries to Michigan Medicaid patients, 127 first-trimester exposures to azatadine and 1311 exposures anytime during pregnancy were recorded. A total of six birth defects were reported with first trimester exposure (5 expected) and included one oral clefts and one limb reduction. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between azatadine and birth defects.

A review of prenatal drug use in 3026 women with premature infants demonstrated an increased risk of retrolental fibroplasia with antihistamine use during the last two weeks of pregnancy. The dosage used or the particular antihistamine was not specified. The incidence of retrolental fibroplasia in premature infants exposed in utero to antihistamine during this time was 21% compared to 11% in premature infants not exposed.

Pseudoephedrine:

A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. Relative risks for other drugs were 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 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 and 1919 exposures anytime during pregnancy were recorded. 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 1980-1983 Medicaid data compared to 3752 pseudoephedrine-exposed pregnancies, providing a relative risk of 1.8. Seven of the nine cases had been exposed to pseudoephedrine and of these 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 anytime during pregnancy, 194 exposures 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.

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Azatadine / pseudoephedrine Breastfeeding Warnings

There are no data on the excretion of azatadine into human milk.

Pseudoephedrine is excreted into human milk. Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached 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, respectively. 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. Pseudoephedrine is considered compatible with breast-feeding by the American Academy of Pediatrics.

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Further information

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