Animal studies of oral administration during days 7 to 17 of gestation in rats showed developmental abnormalities including incomplete ossification at 4 mg/kg/day, cleft palate, microphthalmia, and small ears at 16 mg/kg/day, and developmental mortality at 10 mg/kg/day. The rat no-effect oral dose is 1 mg/kg/day. Bexarotene plasma levels after topical application in chronic T-cell lymphoma (CTCL) patients were usually less than one hundredth of the rat dysmorphogenesis-associated Cmax, although some patients reached levels approximately one eighth the dysmorphogenesis Cmax. There are no controlled data in human pregnancy.

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.

Use is contraindicated.

US FDA pregnancy category: Not assigned

Comments:
-This drug may cause fetal harm.
-Stop use immediately if pregnancy occurs
-Animal oral administration studies during days 7 to 17 of pregnancy showed fetal malformations, developmental abnormalities, developmental mortality, and dysmorphogenesis.
-Advise patients of childbearing potential to avoid pregnancy.
-Consider the possibility of pregnancy at therapy initiation.
-Obtain a negative pregnancy test with a sensitivity of at least 50 mIU/L one week prior to therapy initiation, repeat at least monthly during therapy and for at least 1 month after the end of therapy.
-Dispense only 1 month supplies pending pregnancy test results and reinforcement of counseling to avoid pregnancy.
-Effective contraception should start at least one month prior to therapy initiation and continue through 1 month after therapy completion.
-Two simultaneous reliable contraceptive methods (or abstinence) are recommended during therapy and for at least 1 month after the end of therapy.
-Males with sexual partners who are pregnant or may become pregnant should use condoms during intercourse during therapy and for at least 1 month after the end of therapy.
-Initiate therapy on the second or third day of normal menses.

See references

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.

See references