Summary of Use during Lactation

Because of its lack of sedation and low milk levels, maternal use of fexofenadine would not be expected to cause any adverse effects in breastfed infants. Fexofenadine might have a negative effect on lactation, especially in combination with a sympathomimetic agent such as pseudoephedrine.

Drug Levels

Fexofenadine is an active metabolite of terfenadine.

Maternal Levels. Milk levels have not been measured after fexofenadine administration. However, after 60 mg every 12 hours orally of its parent compound, terfenadine, peak steady-state fexofenadine milk levels averaged 41 mcg/L (range 23 to 60 mcg/L). Based on the data on drug passage into breastmilk in this study and the typical serum levels found after fexofenadine administration, an exclusively breastfed infant would receive less than 0.1% of the weight-adjusted maternal dosage of fexofenadine.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

In one telephone follow-up study of 25 infants exposed to the fexofenadine's parent drug terfenadine, 3 mothers reported irritability in their infants. None of the reactions required medical attention.[2]

Effects on Lactation and Breastmilk

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women.[3,4] However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers.[3] Whether lower oral doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Loratadine

References

1.

Lucas BD Jr, Purdy CY, Scarim SK, et al. Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther. 1995;57:398–402. [PubMed: 7712667]

2.

Ito S, Blajchman A, Stephenson M, et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393–9. [PubMed: 8498418]

3.

Messinis IE, Souvatzoglou A, Fais N, et al. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985;8:143–6. [PubMed: 3928731]

4.

Pontiroli AE, De Castro e Silva E, Mazzoleni F, et al. The effect of histamine and H1 and H2 receptors on prolactin and luteinizing hormone release in humans: Sex differences and the role of stress. J Clin Endocrinol Metab. 1981;52:924–8. [PubMed: 7228996]

Substance Name

Fexofenadine

CAS Registry Number

83799-24-0

Drug Class

Breast Feeding

Lactation

Antihistamines

Nonsedating Antihistamines