Accutane

THE SAFETY OF ISOTRETINOIN DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

Isotretinoin should not be taken during pregnancy because of the increased risk of serious birth defects. Human studies that have looked at the safety of isotretinoin during pregnancy suggest this medication increases the risk of  defects of the baby’s skull, limbs, heart, and face. Due to its toxicity, isotretinoin should be avoided while breastfeeding.

What is Isotretinoin?

Isotretinoin is a medication that is a derivative of Vitamin A and is currently available as a generic and brand name medication. Isotretinoin is available as an oral capsule (Accutane™, Claravis™). Isotretinoin is dosed based on body weight and is taken daily in two separate doses for up to 24 weeks. It is available by prescription from your doctor. 

What is Isotretinoin used to treat?

Isotretinoin is used to treat rosacea and severe, nodular, cystic acne vulgaris in children over 12 years old, adolescents, and adults. Acne vulgaris, also known as acne, is an inflammatory condition of the pilosebaceous unit (hair follicles and sebaceous glands) which causes clogged pores and inflammatory lesions on the skin of the face and upper body. Pregnancy can cause acne to get worse, particularly in women who had acne before becoming pregnant.

You can read about acne and other common skin conditions during pregnancy here.

How does isotretinoin work?

Isotretinoin works by decreasing sebaceous gland size and sebum production in the skin. Isotretinoin also causes high levels of Vitamin A, which affect the development of the baby's face and head. 

If I am taking isotretinoin, can it harm my baby?

The manufacturer warning for isotretinoin states this medication should not be used during pregnancy because of the risk for serious birth defects. Human studies and case reports suggest there is an increased risk of serious birth defects of the head and face with use of this medication during pregnancy.

Evidence from animal studies with isotretinoin:

When isotretinoin was given to mice, head and face birth defects were reported. Similar birth defects have been observed in the offspring of pregnant monkeys, hamsters, rabbits, mice, and rats exposed to isotretinoin doses several times higher than recommended human doses.

Evidence for the risks of isotretinoin in human babies:

Isotretinoin is contraindicated in pregnancy due to its association with an increased risk of birth defects. Isotretinoin should be avoided in pregnant women or women who could become pregnant. There is no specific dose of isotretinoin that has been shown to be safe during pregnancy. There are multiple case reports of children exposed to isotretinoin before conception or during the first trimester who developed birth defects. Reports provided to the manufacturer, the CDC, and FDA in pregnant women exposed to isotretinoin noted a pattern of birth defects that included one or more of the following: brain and spinal cord defects, hydrocephalus, facial nerve palsy, skull defects, blindness, eye defects, facial defects, small head/mouth/ears/jaw, cleft palate, heart defects, liver or urinary tract defects, small limb size, low muscle tone, enlarged scrotum, low nasal bridge, and thyroid defects. The CDC notes there are high miscarriage rates in pregnant women exposed to isotretinoin; therefore, the rates of toxicity and death with this medication may be more common than infants born with birth defects. Premature birth is estimated to be 16% in babies exposed to isotretinoin in utero. Doses of isotretinoin as low as 0.2 to 1.5 mg/kg are associated with adverse outcomes in pregnancies. A report in 56 pregnant women exposed to isotretinoin during the first trimester of pregnancy found a 23% occurrence of birth defects. Other reports suggest the risk of birth defects may be as high as 30% of women exposed to isotretinoin while pregnant. In the general population unexposed to isotretinoin, the rate of major birth defects is 3% to 5%. Paternal exposure to isotretinoin has been involved in three reports of children with birth defects. Studies are ongoing to determine long-term developmental and neurological side effects from in utero isotretinoin exposure; however one study reported decreased intelligence (IQ) scores in 5-year old children exposed to isotretinoin during the first 60 days after conception. A study from 1989 found 85.3% (75/88) of babies born to mothers who discontinued isotretinoin before becoming pregnant were normal and healthy. 

Studies have found an association between an increased risk of birth defects with even short periods of isotretinoin exposure. The rate of elective abortions is high in women who become pregnant while on isotretinoin, particularly women exposed to isotretinoin for two weeks after conception. Some sources recommend discontinuing isotretinoin for at least one month before conception. The manufacturer recommends women have a negative pregnancy test at least 2 weeks before starting isotretinoin. Studies in France and the Netherlands suggest some women may have low compliance with contraceptive use while on isotretinoin. In individuals with child bearing potential, at least two forms of contraception are required while taking this medication. Contraception should be started at least one month before starting isotretinoin, continued while taking this medication, and continued for at least one month after discontinuing this medication. Pregnancy tests are performed monthly while individuals are on isotretinoin. 

Bottom line: Isotretinoin should be not be taken soon before conception or during pregnancy because of an increased risk of skull and facial birth defects. Studies suggest long-term development may also be negatively affected in babies exposed to isotretinoin during pregnancy.

If I am taking isotretinoin and become pregnant, what should I do?

If you are taking isotretinoin and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby. It is recommended to discontinue isotretinoin immediately if you become pregnant while taking it. In women who choose to continue pregnancy after exposure to isotretinoin, additional monitoring is recommended to detect and treat birth defects in utero. Women should be referred to a doctor with expertise in reproductive toxicity for follow-up counseling. The risk of serious birth defects with this medication requires prescriptions in the United States be distributed only through the iPLEDGE program. Patients and physicians must meet specific requirements to be eligible for this program and for use of this medication. In countries such as the Netherlands and Canada that do not have the iPLEDGE program, studies report poor adherence to isotretinoin pregnancy prevention programs. Appropriate counseling on safe and effective contraception for women can decrease anxiety related to use of this medication. 

If I am taking isotretinoin, can I safely breastfeed my baby?

It is unknown if isotretinoin passes into breast milk. However, it is expected to pass into the breast milk. There have been reports of enlarged breasts and nipple secretions in women who used isotretinoin. Due to the potential risk to the nursing infant, isotretinoin is not recommended while breastfeeding or for at least one month after discontinuing breastfeeding. Mothers should either discontinue isotretinoin or discontinue breastfeeding. 

Bottom line: Due to the potential risk to the nursing infant, isotretinoin is not recommended while breastfeeding or for at least one month after discontinuing breastfeeding. Women should choose to either discontinue breastfeeding while on this medication or discontinue the medication while breastfeeding.

If I am taking isotretinoin, will it be more difficult to get pregnant?

Studies suggest isotretinoin does not interfere with the effectiveness of oral contraceptives. In males using isotretinoin
, it has been shown to be present in semen. However, the amount of isotretinoin expected to reach a female partner is minimal. Studies in men suggest isotretinoin has no impact of sperm count or health. However, other studies suggest male exposure to this medication can have a negative impact on male fertility. A study in dogs suggest isotretinoin given at 10-30 times the recommended human dose can decrease sperm count. Rats treated with less than 5 times the recommended human dose of isotretinoin experienced no negative effects on fertility. Studies in animals suggest isotretinoin may have negative effects on male and female fertility. 

 If I am taking isotretinoin, what should I know?

Isotretinoin should not be used during pregnancy. Studies show there is an increased risk of serious birth defects with use of this medication soon before conception or during pregnancy. Birth defects may include deformities of the skull, face, limbs, and heart. Long-term effects on intelligence and neurological development have been reported in babies exposed to isotretinoin in utero. Isotretinoin is considered toxic and should be avoided in women who are breastfeeding a baby.

If I am taking any medication, what should I know?

This report provides a summary of the available information about the use of isotretinoin during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about acne here and reports about various skin conditions and the individual medications used to treat them here.  Additional information can also be found in the links below. 

For more information about azelaic acid during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:

U.S. National Library of Medicine: LACTMED: ISOTRETINOIN

U.S. Food and Drug Administration: Accutane Prescribing Information

Read the whole report
Last Updated: 12-09-2019
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.