Diphenhydramine topical Pregnancy and Breastfeeding Warnings

Brand names: Aller-Dryl, Banophen M-S, Benadryl Extra Strength Itch Stopping Gel , Derma-Pax, Dermamycin, Dermarest, Dermarest Anti-Itch, Dermarest Plus, Itch Relief, Tecnu Calagel, The Itch Eraser, Valu-Dryl Topical

Diphenhydramine topical Pregnancy Warnings

The Collaborative Perinatal Project reported 595 first-trimester exposures and 2,948 exposures anytime during pregnancy. No relationship was found to large categories of malformations. Possible associations with individual malformation were found. One study reported a statistical relationship between oral diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of oral diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital.

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.

Oral diphenhydramine has been shown to have oxytocic effects in animal and human uteri. One case report of a pregnant woman who ingested a large amount of diphenhydramine in an attempted suicide developed strong, regular uterine contractions that were halted by the administration of intravenous magnesium. Because of the large amount of diphenhydramine ingested by this pregnant woman in her attempted suicide and the small amount absorbed through the skin into systemic circulation, oxytocic effects would not necessarily be expected in pregnant women using the topical form of diphenhydramine.

Diphenhydramine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal teratogenicity. There are no controlled data in human pregnancy. Diphenhydramine topical should be used during pregnancy only when need has been clearly established.

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Diphenhydramine topical Breastfeeding Warnings

There are no data on the excretion of diphenhydramine topical into human milk. However, orally administered diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. The manufacturer of diphenhydramine topical has no lactation warning in the product labeling. However, the manufacturer of oral diphenhydramine 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. Potential risk from diphenhydramine would be expected to vary with the amount of the drug the mother (and therefore, the child) absorbs into their body.

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