Preventing birth defects caused by isotretinoin

July 2, 2019

If you’re planning to get pregnant, it’s important to talk to your health care provider about any medicine you take. That’s because taking certain medicines during pregnancy can increase your baby’s risk of having a birth defect. Isotretinoin is a prescription medicine that’s especially dangerous for your baby.

Isotretinoin is a kind of medicine called an oral retinoid. Oral means that you take it by mouth. Retinoids are man-made forms of vitamin A used to treat certain skin conditions and blood cancers. Isotretinoin is mainly used to treat a severe type of acne called nodular acne that causes large, painful lumps in the skin.

Providers prescribe isotretinoin only when other acne treatments don’t work. Accutane® is the original brand of isotretinoin. Accutane is no longer sold, but these brands are still used: Absorica®, Amnesteem®, Claravis®, Myorisan® and Zenatane®.

How can isotretinoin affect your baby during pregnancy?

Taking isotretinoin during pregnancy increases your baby’s risk of:

  • Miscarriage. This is when a baby dies in the womb before 20 weeks of pregnancy.
  • Premature birth. This is birth that happens too soon, before 37 weeks of pregnancy.
  • Birth defects. Birth defects are health conditions that are present at birth. They change the shape or function of one or more parts of the body. Birth defects can cause problems in overall health, how the body develops or how the body works.
  • Intellectual and developmental disabilities. These are problems with how the brain works that can cause a person to have trouble or delays in physical development, learning, communicating, taking care of himself or getting along with others.

Can you prevent birth defects caused by isotretinoin?

Yes. To prevent birth defects in your baby, plan your pregnancy so you’re not taking isotretinoin during pregnancy and for at least 1 month before you get pregnant. Here’s how:

If you’re planning to use isotretinoin:

  • Talk to your provider about the iPLEDGE program. This program provides strict rules for isotretinoin users. The Food and Drug Administration (also called FDA) requires women and men to register with this program and agree to these rules before using the medicine.
  • Use two forms of effective birth control for at least 1 month before taking isotretinoin, while taking isotretinoin and for 1 month after you stop taking isotretinoin. Your provider can help you choose two effective forms of birth control that work well together.
  • If you take birth control pills, tell your provider what you take. Some may not work if you take them with isotretinoin, so you may need to switch to a different pill.

If you’re using isotretinoin and thinking about getting pregnant:

  • Use two forms of effective birth control to prevent pregnancy.
  • Tell your provider. You can work together to plan to stop taking the medicine at least 1 month before you get pregnant.

If you’re using isotretinoin and you get pregnant, tell your provider right away. If you’re pregnant, don’t take isotretinoin.

If your male partner uses isotretinoin and you’re pregnant or thinking about getting pregnant:

  • Talk to your provider. Men who take isotretinoin can have a very small amount of it in their semen (fluid that contains sperm). Experts don’t know if semen with isotretinoin can lead to birth defects.
  • Use a male latex condom every time you have sex to help prevent pregnancy while your partner is taking isotretinoin and for 1 month after he stops taking it.

To learn more about isotretinoin and medicine safety during pregnancy, visit marchofdimes.org.

Please be advised that the content in this blog post is from more than two years ago and may no longer be up-to-date. For inquiries regarding your health, it is recommended to seek advice from a healthcare provider.