This drug is teratogenic in rats and rabbits. Following topical dermal application at 0.25 mg/kg/day during organogenesis, this drug was associated with reduced fetal body weights and reduced skeletal ossification in rats and an increased incidence of known retinoid malformations (including spina bifida, hydrocephaly, and heart anomalies) in rabbits. There are no controlled data in human pregnancy. Eight women inadvertently exposed to this drug during pregnancy in clinical trials gave birth to healthy babies.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

Contraindicated

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Based on data from animal studies, retinoid pharmacology, and the potential for systemic absorption, this drug may cause fetal harm and therefore is contraindicated during pregnancy

Comments:
-A negative pregnancy testing should be obtained within 2 weeks of initiating therapy; this drug should be started during a normal menstrual period.
-If pregnancy occurs during treatment, this drug should be discontinued and women apprised of the potential hazard to the fetus; women of child-bearing potential should be warned of potential risks to the fetus and advised to use effective contraception.

See references

Benefit should outweigh risk

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

Comments:
-This drug has not been studied during breastfeeding; there is no information regarding the effects on the breastfed infant or the effects on milk production. For this reason, some authorities recommend against use.
-Other authorities feel it is okay to use if required by the mother and use is limited to less than 20% body surface area because of possible absorption; if used, ensure infant skin does not come into direct contact with the areas of maternal skin that have been treated and that the infant does not ingest product from mother's skin.

See references