Bexarotene (systemic) (monograph) Pregnancy Warnings
This drug is a retinoid, a drug class associated with birth defects in humans. Additionally, animal studies have revealed evidence of developmental mortality, teratogenicity (e.g., cleft palate, incomplete ossification, depressed eye bulge/microphthalmia, small ears), testicular degeneration, and reversible aspermatogenesis.
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.
UK: Use is contraindicated during pregnancy and in women of childbearing potential without effective birth control measures.
US: Use is contraindicated during pregnancy.
US FDA pregnancy category: Not Assigned
Comments:
-Negative pregnancy tests (e.g., serum beta-human chorionic gonadotropin [beta-HCG]) with sensitivity of at least 50 mIU/L should be obtained within one week prior to therapy and at monthly intervals during treatment.
-Female patients of reproductive potential should use effective contraception for one month prior to therapy initiation, during therapy, and for at least one month following treatment discontinuation.
-Two reliable forms of contraception should be used simultaneously; one form should be non-hormonal as this drug may reduce the efficacy of oral and other systemic hormonal contraceptives.
-Male patients should use condoms during treatment and for at least one month after the last dose if they have sexual partners who are pregnant or of childbearing potential.
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