Tazarotene topical Pregnancy and Breastfeeding Warnings
Tazarotene topical Pregnancy Warnings
Women of childbearing potential should use adequate birth control measures when tazarotene topical is used. A negative pregnancy test with a sensitivity of at least 50 milli-international units/mL for hCG (recommended for the cream and gel) or a sensitivity of at least 25 milli-international units/mL for hCG (recommended for the foam) should be obtained within two weeks before the initiation of tazarotene therapy, which should begin during a normal menstrual period.
Tazarotene topical has been assigned to pregnancy category X by the FDA. Animal studies have revealed reduced fetal body weights, reduced skeletal ossification, single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. There are no controlled data in human pregnancy. Eight women inadvertently exposed to the drug during pregnancy in clinical trials gave birth to healthy babies. Tazarotene topical is considered contraindicated during pregnancy.
Tazarotene topical Breastfeeding Warnings
Animal studies have reported that radioactivity was detected in milk after a single dose of radioactive tazarotene was applied to the skin of lactating rats.
There are no data on the excretion of tazarotene into human milk. The manufacturer recommends that caution be used when administering tazarotene topical cream or gel to nursing women. Because the safe use of tazarotene topical foam during lactation has not been established, the manufacturer recommends that a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
References for pregnancy information
- "Product Information. Tazorac (tazarotene topical)." Allergan Inc, Irvine, CA.
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