Isotretinoin (Accutane®)

Pregnancy

Isotretinoin and its metabolites (the compounds that are released when isotretinoin is broken down in the body) cross the placenta and is transferred to the fetus when taken during pregnancy. Isotretinoin is contraindicated in women who are pregnant or have the ability to become pregnant and are not on adequate contraception, because of the risk of severe birth defects. Isotretinoin also increases the risk of spontaneous abortion and premature births. Therefore, both men and women who are about to start isotretinoin, their prescribers, and pharmacists must register for iPLEDGE risk evaluation and reduction. 

Category: X

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excretion into human milk: Unknown

There are no studies that have investigated the risk to infants when isotretinoin was used during breastfeeding. However, breastfeeding is not recommended while taking isotretinoin because of potentially serious adverse effects.