Why Pregnancy Is of Concern for Women Taking Accutane

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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 your baby. For this reason, it's important to be careful that pregnancy does not occur 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. The risks associated with taking isotretinoin during pregnancy are well known and include miscarriage and birth defects.

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 pregnant women 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, in 2006, the manufacturers of isotretinoin came up with the IPledge program, which monitors the compliance of medication users to avoid inadvertent (or intentional) pregnancy while on Accutane. The program is mandatory for everyone who takes isotretinoin, though there are separate requirements for women and men. It should be noted, however, that there are no known cases of birth defects caused by a man 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 if a pregnant woman receives it.

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, several hundred women still get pregnant while taking this medication each year.

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 will still depend on your plans for pregnancy. Your dermatologist can prescribe other medications, such as oral antibiotics or topical ointments, to treat your acne. Additionally, over-the-counter treatments are also available. Consult with your doctor to find out what is best—and safe—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.

Try these safe strategies for dealing with acne during 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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  1. Webster GF Md. Isotretinoin: Mechanism of action and patient selectionSemin Cutan Med Surg. 2015;34(5 Suppl):S86-S88. doi:10.12788/j.sder.2015.0163

  2. Choi JS, Koren G, Nulman I. Pregnancy and isotretinoin therapyCMAJ. 2013;185(5):411-413. doi:10.1503/cmaj.120729

  3. Tkachenko E, Singer S, Sharma P, Barbieri J, Mostaghimi A. US Food and Drug Administration reports of pregnancy and pregnancy-related adverse events associated with isotretinoin. JAMA Dermatol. 2019;155(10):1175-1179. doi:10.1001/jamadermatol.2019.1388

  4. MedlinePlus. Isotretinoin. Updated April 20, 2020.

  5. Pierson JC, Ferris LK, Schwarz EB. We pledge to change iPLEDGE. JAMA Dermatol. 2015;151(7):701-2. doi: 10.1001/jamadermatol.2015.0736.

  6. Zomerdijk IM, Ruiter R, Houweling LM, et al. Isotretinoin exposure during pregnancy: A population-based study in The NetherlandsBMJ Open. 2014;4(11):e005602. doi:10.1136/bmjopen-2014-005602

  7. US Food & Drug Administration ACCUTANE® (isotretinoin capsules). 2008.

  8. Baldwin HE. Pharmacologic treatment options in mild, moderate, and severe acne vulgarisSemin Cutan Med Surg. 2015;34(5 Suppl):S82-S85. doi:10.12788/j.sder.2015.0162

  9. American Academy of Dermatology Association. 10 things to try when acne won’t clear.