Is it safe to take Accutane during pregnancy?

I am considering getting pregnant however I am in the middle of a 10-month Accutane program. We are using contraception but what would happen if I got pregnant before the treatment ended?


F, 31, Virginia

Tags:acne pregnancy cystic acne

According to the U.S. Food and Drug Administration (FDA), if you are pregnant or planning to become pregnant it is critical that you avoid Accutane. Accutane is no longer distributed in the U.S. under this brand name but under other names, including isotretinoin, Amnesteem, Claravis and Sotret. The drug and its derivatives have been classified by the FDA as Category X,  the most severe drug advisory category possible.

Category X drugs are contraindicated during pregnancy because they have been linked to high numbers of birth defects in babies whose mothers have taken them. If you are sexually active and taking isotretinoin or any similar oral retinoids, ensure you use two forms of effective birth control or abstain from sexual activity until you have completed your treatment.

The FDA recommends that if a woman does fall pregnant while taking isotretinoin, she should talk to her treatment provider about the desirability of continuing the pregnancy. CDC reports provide evidence that isotretinoin is a teratogen, an agent that interferes with the normal development of an embryo. Clinical studies show that the drug results in an incidence of 25.6% of babies being born with developmental problems. Some neonatal effects include severe birth defects, such as:

  • Cleft palate
  • Hydrocephaly (large fluid spaces in the baby's brain)
  • Microcephaly (unusually small head)
  • Eye abnormalities
  • Ear abnormalities
  • Intellectual disabilities
  • Malformations in the central nervous system
  • Heart defects
  • Facial dysmorphism

The risk of isotretinoin resulting in birth defects is so serious that systems have been put in place by the FDA to ensure safe prescription of the drug in the U.S. The current system is called iPledge and it aims to prevent pregnant women from taking isotretinoin and prevent pregnancies in women already taking the drug. Every isotretinoin distributor and prescribing healthcare professional is obligated to register through the iPledge database.

Medical professionals must counsel patients about the risk of isotretinoin and sign iPledge forms stating that patients have received this counseling. If you are in the middle of a 10-month course of isotretinoin, your health care provider should inform you about the associated risks during each monthly treatment.

It is imperative that you avoid Accutane (currently more commonly referred to by its generic name, isotretinoin) if you are planning on becoming pregnant. Isotretinoin is a retinoic acid derived from vitamin A that is highly effective at improving severe acne by shrinking the sebaceous glands and reducing oil production.

However, it is contraindicated in pregnant women as it can have negative effects on the embryo, resulting in potential miscarriage, premature birth or infant death. It can also cause birth defects, including craniofacial, cardiovascular, and central nervous system malformations.

The risk of these conditions among the baseline population is 3-5% but climbs to almost 30% among women exposed to isotretinoin during the first trimester of their pregnancy. For this  reason, women of childbearing age should take a pregnancy test before they begin a course of isotretinoin. They should also use an effective form of birth control and a backup method on top of that. Female patients taking isotretinoin must register with the iPledge program. iPledge is an FDA-approved program designed to inform people about the risk of birth defects associated with isotretinoin and to prevent women who are taking isotretinoin from becoming pregnant.

If you wish to get pregnant after a course of isotretinoin therapy, wait at least four weeks after your treatment is complete. Nursing mothers must also avoid isotretinoin, as it is unclear whether or not the drug affects breast milk. If you fall pregnant while following a course of this medication, stop taking it immediately and inform your doctor of the situation.