Pseudoephedrine / terfenadine Pregnancy and Breastfeeding Warnings

Brand names: Seldane-D

Pseudoephedrine / terfenadine Pregnancy Warnings

Terfenadine-pseudoephedrine has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy for terfenadine or pseudoephedrine. Terfenadine-pseudoephedrine should only be used during pregnancy if benefit outweighs the risk to the fetus.

Terfenadine:

In a review of 229,101 deliveries to Michigan Medicaid patients, 1034 first-trimester exposures to terfenadine and 2042 exposures anytime during pregnancy were recorded. A total of 51 birth defects were reported with first-trimester exposure (44 expected) and included (observed/expected) 13/10 cardiovascular defects, 2 oral clefts, 12/2 polydactyly, and 3/1 limb reduction defects. A significant relative risk exists for polydactylies (5.4) and limb reduction defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

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 heterogeneous defects suspected to have a vascular etiology was reviewed. 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 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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Pseudoephedrine / terfenadine Breastfeeding Warnings

There are no data on the excretion of terfenadine 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 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 in breast milk. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

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Further information

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