Fexofenadine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brand names: Allegra-D 12 Hour, Allegra-D 12 Hour Allergy & Congestion, Allegra-D 24 Hour, Allegra-D 24 Hour Allergy & Congestion

Medically reviewed by Drugs.com. Last updated on Aug 8, 2024.

Fexofenadine / pseudoephedrine Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-Pseudoephedrine use during the first trimester may be associated with gastroschisis and small intestinal atresia (SIA); data is limited and unconfirmed, risk appears to be low (only identifiable by case-control studies), and may only occur in combination products, but avoidance during the first trimester is nonetheless recommended.
-Prostaglandin synthesis inhibitors like ibuprofen may cause persistent pulmonary hypertension of the newborn when given during the third trimester close to delivery.
-Consider using a first-generation antihistamine (e.g. chlorpheniramine) during pregnancy, as extensive human data is available.

Fexofenadine: Animal studies of fexofenadine showed dose-related embryofetal toxicity. Animal studies of fexofenadine (assessed through terfenadine exposure) showed no evidence of teratogenicity at up to 300 mg/kg/day (about 4 to 32-fold the recommended human dose) orally throughout organogenesis; decreased pup weight was seen at 150 mg/kg/day and higher.

Pseudoephedrine: A monitoring study of 50, 282 mother/child pairs (3082 first trimester sympathomimetic drug exposures, 9719 any time pregnancy exposures) suggested a link to categories of minor malformations (non-life-threatening, no major cosmetic defects) including inguinal hernia and clubfoot. Pseudoephedrine may be associated with gastroschisis, but this may also be caused by maternal health factors. First trimester oral decongestant exposure or maternal smoking may increase the risk of gastroschisis, small intestinal atresia (SIA), and hemifacial microsomia.

There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Fexofenadine / pseudoephedrine Breastfeeding Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus.

Excreted into human milk: Yes (fexofenadine and pseudoephedrine)

Comments:
-Peak steady state fexofenadine milk levels (after administration of the parent compound terfenadine) averaged 41 mcg/L (range 23 to 60 mcg/mL).
-It is estimated the infant would be exposed to about 0.1% of the parental fexofenadine dose.
-Irritability was reported in breastfed infants whose mothers took terfenadine.
-The small amounts of pseudoephedrine (about 4.3 to 5.5% of maternal dose) may cause occasional irritability.
-A single pseudoephedrine dose acutely decreases milk production (average 24%); repeated use interferes with lactation.
-Do not use pseudoephedrine in patients with insufficient milk production or in those just establishing lactation.

See references

Further information

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