Why Pregnancy Is of Concern for Women Taking Accutane

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Accutane is a medication that was used to treat severe acne. It is currently known as isotretinoin and is also marketed as Claravis, Sotret, and Amnesteem. It is an oral medication taken once or twice a day to 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 can be serious.

Isotretinoin Risks During Pregnancy

Isotretinoin is teratonogenic, 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 30% of infants are born with a defect. These infants may also have a higher rate of intellectual disability and impaired neuropsychologic function.

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 one month after treatment in order to prevent pregnancy.

Why the IPledge Program Is Required for Those Taking Accutane

To combat these risks, the manufacturers of isotretinoin came up with the IPledge program. It is for everyone who takes the medication, though there are separate requirements for women and men.

If you are taking isotretinoin, you are required to participate in the IPledge program even if you cannot get pregnant or get someone else pregnant (for example, you have had a hysterectomy).

Other than birth control, the other requirements of the IPledge program include monthly pregnancy tests during treatment and prescription parameters.

While the program initially showed promise, several reports have indicated the system has not worked as well as hoped. While the rate of birth defects is down, lower numbers of people are taking the medication as prescribed. 

If you are currently pregnant or trying to become pregnant, you would not be able to use isotretinoin to treat your acne.

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.

What Happens if You Take Isotretinoin While Pregnant

About 42% of infants born after being exposed to isotretinoin in pregnancy had some form of birth defect or died.

Of the infants who had Accutane-relatead birth defects, there were both internal and external abnormalities such as cleft palate, missing ears, facial dysmorphism, and central nervous system malformations.

When Accutane was available, its pregnancy labeling was Category X, meaning there were known deformities caused by the medication, and that it should not be taken during pregnancy.

It was also determined that pregnancy-related risk is still present for a month or two after stopping isotretinoin.

Alternatives to Accutane

While Accutane is not currently available, isotretinoin is—though it is not a safe option for treating acne while you are pregnant.

There are alternatives to Accutane, though your options will still depend on your plans for pregnancy.

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 your options with your dermatologist. It may also be useful to discuss acne treatment with your obstetrician or midwife during your pre-conceptional health visit.

What to Do About Acne During Pregnancy

Pregnancy has the potential to give you more acne than you had in high school. You may well need to think about safe options for treating it. Here are some ways to deal with acne during pregnancy that don't carry the risks associated with Accutane.

  • Wash your face at least twice a day.
  • Wash and change your pillowcases once a week.
  • Use oil-free makeup products.
  • Remove all makeup from your face at the end of the day.
  • Go makeup-free when possible.
  • Find over-the-counter products that are safe in pregnancy. Your doctor or midwife can help you.
  • Stay well hydrated.
  • Good nutrition will help your skin overall.

In the end, you will be glad that you either waited to treat your acne until after your baby was born, or that you delayed pregnancy until after your treatment was finished. This is the best for you and your pregnancy.

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Article Sources
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  1. 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

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

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

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

Additional Reading
  • Drug Watch: Accutane. May 2016.

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

  • Baldwin HD. "Pharmacologic Treatment Options in Mild, Moderate, and Severe Acne Vulgaris." Semin Cutan Med Surg. 2015 Sep;34(5S):S82-S85.
  • Webster GF. "Isotretinoin: Mechanism of Action and Patient Selection." Semin Cutan Med Surg. 2015 Sep;34(5S):S86-S88.