Dangers of Accutane During Pregnancy

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Accutane (isotretinoin) is a retinoid medication that is commonly used to treat severe acne. The drug is often very effective, but taking it while pregnant can cause serious, even deadly complications for babies. For this reason, it's very important to prevent pregnancy while taking the drug.

While Accutane is the best-known brand name, isotretinoin is also marketed as Claravis, Sotret, and Amnesteem. It is an oral medication taken once or twice a day over a period of several months to help decrease acne. Isotretinoin is often prescribed for teens and young adults—an age group that is at peak childbearing potential.

Isotretinoin Risks During Pregnancy

Isotretinoin is a known teratogen, which means it can cause birth defects. When taken in the first trimester, isotretinoin can cause facial, heart, thymic, and central nervous system malformations. In addition, the miscarriage rate is approximately 20% in people exposed to isotretinoin. Of the pregnancies that progress, approximately 20% to 35% of infants are born with a defect.

These infants may also have a higher rate of intellectual disability and impaired neuropsychologic function, which includes cognitive function like memory and executive function. It is estimated that between 30% to 60% of children exposed to isotretinoin in utero will go on to show neurocognitive impairment.

If you are taking Accutane, you must use two methods of birth control for one month prior to treatment, during the entire 16- to 20-week treatment cycle, and for at least one month after treatment in order to prevent pregnancy.

The IPledge Program

To combat the potential for birth defects and other dangerous side effects, the manufacturers of isotretinoin came up with the IPledge program in 2006. This program monitors the compliance of medication users to avoid inadvertent (or intentional) pregnancy while on Accutane.

Participating in the program is mandatory for everyone who takes isotretinoin, though there are separate requirements for people who can become pregnant. There are no known cases of birth defects caused by a male partner taking the drug.

If you are taking isotretinoin, you are required to participate in the IPledge program even if you are not sexually active, cannot get pregnant, or cannot get someone else pregnant (for example, if you have had a hysterectomy or vasectomy). However, the requirement to use two forms of birth control can be waived for those who can't become pregnant or are not sexually active.

In addition to using birth control, the other requirements include monthly pregnancy tests prior to and during treatment as well as logging on to the IPledge website to complete information before prescriptions can be released. It is also not safe to give blood while being treated by this medication (and for one month after treatment), as the donor blood could cause birth defects in a pregnant recipient.

While the program has reduced rates of pregnancy while taking the medication, several reports have indicated the system has not worked as well as hoped. Unfortunately, while the rate of Accutane-related birth defects is down since the introduction of IPledge, every year several hundred people still get pregnant while taking this medication.

If you are not yet pregnant but are considering trying to conceive, you would need to decide whether the 16- to 20-week course of treatment for your acne is worth the wait. Alternatively, you could wait until you have completed your pregnancy to begin treatment with isotretinoin.

The bottom line is that if you are currently pregnant or trying to become pregnant, you should never use isotretinoin to treat your acne.

Isotretinoin-Related Birth Defects

Unfortunately, due to misinformation and other factors, some people do not comply with the IPledge program and/or accidentally get pregnant and end up taking isotretinoin while carrying a child. As noted above, the babies exposed to the medication are at increased risk of miscarriage, preterm labor, birth defects, and intellectual disabilities.

Of the infants who had Accutane-related birth defects, there were both internal and external abnormalities, such as cleft palate, missing ears, facial dysmorphism (structural abnormalities), microcephaly (a smaller than expected head), and central nervous system malformations. Problems with the heart, eyes, and thyroid can also occur.

As the pregnancy-related risk of birth defects is still present for at least a few weeks after stopping isotretinoin, it is recommended that conception not take place (and birth control measures be continued) for a minimum of a month after ending treatment. However, in an abundance of caution, some researchers and doctors advise a longer window of three months for avoiding pregnancy to ensure that all of the medication has left the body.

Alternatives to Accutane

There are alternatives to Accutane, though your options still depend on your plans for pregnancy. A dermatologist can prescribe other medications, such as oral antibiotics or topical ointments, to treat acne. Additionally, over-the-counter treatments are also available. Consult with your doctor to find out what is best—and safest—for you to take to treat the type of acne you have.

If you have acne and need medication to treat it, but you are considering trying to conceive or are currently pregnant, you will need to discuss pregnancy-safe options with your dermatologist. It may also be useful to discuss acne treatment with your obstetrician or midwife during your pre-conceptional health visit as well.

Coping With Acne During Pregnancy

The surge of hormones that occurs during pregnancy has the potential to give you more acne than you had in high school. You may want to think about safe options for treating it. These strategies for dealing with acne during and after pregnancy that don't carry the risks associated with Accutane.

  • Find over-the-counter acne products that are safe in pregnancy. Your doctor or midwife can help you.
  • Go makeup-free when possible.
  • Eat a healthy diet, avoiding unhealthy fats and added sugars.
  • Remove all makeup from your face at the end of the day.
  • Stay well hydrated.
  • Use oil-free makeup products.
  • Wash and change your pillowcases once a week.
  • Wash your face at least twice a day.

A Word From Verywell

The possible consequences of taking isotretinoin during pregnancy are severe and irreversible. In the end, the only sure way to protect your unborn child is to wait to take Accutane until after your baby is born or to delay pregnancy until after your treatment. If that's not possible, it is imperative that you use multiple forms of birth control—and use them correctly. This is the best for you, your pregnancy, and your baby.

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9 Sources
Verywell Family uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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By Robin Elise Weiss, PhD, MPH
Robin Elise Weiss, PhD, MPH is a professor, author, childbirth and postpartum educator, certified doula, and lactation counselor.