Halobetasol / tazarotene topical Pregnancy and Breastfeeding Warnings

Brand names: Duobrii

Medically reviewed by Drugs.com. Last updated on May 5, 2023.

Halobetasol / tazarotene topical Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on data from animal reproduction studies, this combination drug may cause fetal harm when administered during pregnancy. Safety in human pregnancy has not been established. The potential risk to the fetus outweighs the potential benefit to the mother; therefore, therapy should be discontinued as soon as pregnancy is confirmed.

Comments:
-Studies suggest an increased risk of low birthweight in infants with the maternal use of potent or very potent topical corticosteroids.
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

In animal studies, the tazarotene component of this drug combination is teratogenic, and it is not known what level of exposure is required for teratogenicity in humans. Animal studies also revealed reduced fetal body weights and reduced skeletal ossification after topical administration of this drug combination. Incidences of retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies were observed after topical administration of a tazarotene gel formulation at 116 times the MRHD. Studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency; however, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants.

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.

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Halobetasol / tazarotene topical Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-There are no data on the use of this combination drug while breastfeeding.
-It is unlikely that short-term application of topical corticosteroids (such as halobetasol) would pose a risk to the breastfed infant by passage into breastmilk; however, experts recommend using the least potent drug on the smallest area of skin possible. Infant skin should not come into direct contact with the areas of skin that have been treated. Only the lower potency corticosteroids should be used on the nipple or areola where the infant could directly ingest the drugs from the skin; avoid halobetasol on the nipple. Only water-miscible creams or gels should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking. Any topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.
-Topical tazarotene has not been studied during breastfeeding. Some experts feel it should not be used on greater than 20% of the body surface area while nursing because of possible absorption.
-Advise breastfeeding women not to apply this drug combination directly to the nipple and areola to avoid direct infant exposure.

See references

Further information

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