Clofazimine Pregnancy and Breastfeeding Warnings

Brand names: Lamprene

Clofazimine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: There is no data available on the use of this drug in pregnant women to inform a drug-related risk. Based on findings from animal studies, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Advise pregnant women of the potential risk to the fetus.
-Perform a pregnancy test in females of childbearing potential prior to starting treatment.
-Counsel sexually active females of reproductive potential to use effective contraception during therapy and for at least 4 months after stopping treatment.
-Advise males taking this drug to use a condom during intercourse while on treatment and for at least 4 months after the last dose.
-The skin of infants born to pregnant mothers treated during pregnancy was pigmented at birth; however, based on reported cases, skin discoloration was reversible and gradually faded over the first year.

Animal studies have revealed evidence of embryofetal toxicity. Administration of this drug to pregnant mice resulted in fetal skull ossification, increased incidences of abortions and stillbirths, and impaired neonatal survival at doses less than the maximum recommended human daily dose (MRHD) based on surface area comparisons. The skin and fatty tissue of mice offspring was discolored after birth, likely due to drug exposure from maternal milk. Other animal studies conducted prior to current regulatory standards did not observe developmental effects at doses up to 2.4 times the MRHD. Animal studies have observed impaired female fertility; there are no non-clinical data on male fertility. 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.

See references

Clofazimine Breastfeeding Warnings

This drug has been used without serious toxicity; however, an alternate therapy might be considered.

Excreted into human milk: Yes, in relatively large amounts; milk may be colored pink to red.

Comments:
-Reversible skin discoloration has been observed in breastfed infants of mothers receiving this drug.
-Human milk enhances the solubilization and possibly the absorption of clofazimine in infants.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer