Alitretinoin topical Pregnancy and Breastfeeding Warnings

Brand names: Panretin

Medically reviewed by Drugs.com. Last updated on Oct 9, 2023.

Alitretinoin topical Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: D

Comments:
-May cause fetal harm if significant absorption occurs; advise women of child bearing potential to avoid becoming pregnant while using this drug.
-Use of adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of fetal harm and teratogenicity with oral doses about 5 times the estimated daily human topical dose and higher. The topical formulation has not been studied in animal models. There are no controlled data in human pregnancy.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Alitretinoin topical Breastfeeding Warnings

Use is not recommended.

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

Comments:
-Due to the potential for adverse effects in the nursing infant, breastfeeding should be discontinued prior to using this drug.

See references

Further information

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