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Isotretinoin is a member of a family of drugs called retinoids, which are related to vitamin A. When taken during pregnancy, isotretinoin and other retinoids can cause miscarriage or very serious birth defects.
Who should not take isotretinoin?
Women who are pregnant, planning pregnancy, having sex without birth control or breastfeeding should not take isotretinoin.
What birth defects are caused by use of isotretinoin during pregnancy?
There is an extremely high risk of birth defects if a woman takes isotretinoin during pregnancy, even if she takes a small amount of the drug for a short period. Birth defects caused by isotretinoin include (1):
Isotretinoin can cause birth defects in the early weeks after conception when a woman may not know she is pregnant. Even babies born without obvious birth defects may have intellectual disabilities or learning disabilities (1). The drug also increases the risk of premature birth and infant death.
What is nodular acne?
Nodular acne causes many red, swollen lumps in the skin and can leave permanent scars. This form of acne sometimes does not respond to treatments other than isotretinoin. The drug clears the skin of most affected individuals for prolonged periods.
What is iPLEDGE?
All patients, including men, who take isotretinoin, must participate in a risk-management program called iPLEDGE. This program was started in 2005 by the Food and Drug Administration (FDA) with two goals (2):
The FDA approved the first form of the drug, Accutane, in 1982. Before it was approved, testing had shown that the drug could cause birth defects in animals. The manufacturer of Accutane, Roche Pharmaceuticals (a division of Hoffmann-La Roche, Inc.), warned against its use by pregnant women, but pregnancies resulting in birth defects still occurred. Subsequently, the FDA and the manufacturers of all brands of isotretinoin implemented voluntary risk-management plans to prevent pregnant women from using the drug. These programs were not successful in preventing drug exposure during pregnancy. As a result, the FDA started iPLEDGE, a stronger, mandatory risk-management program.
What should a woman of childbearing age do before taking isotretinoin?
A woman should discuss with a health care provider who is experienced in isotretinoin treatment whether the drug is right for her. Besides causing birth defects, isotretinoin can cause serious side effects for the woman, possibly including mental health problems (3). In many cases, safer treatments may work to clear up acne.
If a woman decides to take isotretinoin, she must follow the steps required by iPLEDGE.
What does iPLEDGE require for women who can become pregnant?
iPLEDGE requires that a woman follow these steps before, during and after isotretinoin treatment:
Before treatment (3):
Each month a woman receives a 30-day supply of isotretinoin. To refill her prescription, she must:
If a woman taking isotretinoin does become pregnant, she should stop taking the drug and call her health care provider. She or her provider must report the pregnancy to the FDA at (800) FDA-1088 and to iPLEDGE (3). Reporting allows the FDA and the drug companies who make isotretinoin to monitor the success of the iPLEDGE program and to make any necessary changes to prevent pregnancy exposures.
A woman should never attempt to get isotretinoin over the Internet because she will miss out on important safeguards to protect her health. The FDA provides more information about the dangers of buying isotretinoin on its Web site.
Is it safe to breastfeed while taking isotretinoin?
Women should not breastfeed while using isotretinoin and for 1 month after stopping the drug because it is not known whether it could harm the baby (3).
What other precautions should a woman take during treatment with isotretinoin?
Most women are treated with isotretinoin for about 4 to 5 months (3). During this time a woman should check with her provider before taking any other medications. A woman should avoid certain drugs and supplements while she is taking isotretinoin (3):
Women and men who use isotretinoin should not give blood while taking the drug and for 1 month afterward, because the drug might cause birth defects if a pregnant woman receives the blood (3). Individuals should never share their prescription for isotretinoin with anyone else.
What are other iPLEDGE requirements?
All providers who prescribe the drug and pharmacists who sell it must register with iPLEDGE (1). Each must agree to certain responsibilities for preventing pregnant women from taking the drug. For example, providers are responsible for counseling women about birth control and the risks of isotretinoin, explaining the iPLEDGE program, and documenting in iPLEDGE a negative pregnancy test for women taking the drug each month. Pharmacists can fill a prescription only after receiving authorization from iPLEDGE. These requirements should help ensure that each woman has had an appropriately timed negative pregnancy test before starting the drug and each month before she refills her prescription. The requirements also should help ensure that all women of childbearing age receive continuing counseling about the safety precautions necessary to prevent fetal exposure to the drug.
Are there safer acne medications for women of childbearing age?
Most women with acne do not have severe nodular acne, and their skin problems often respond to safe topical (applied to the skin) or oral medications. Topical preparations of the antibiotics erythromycin or clindamycin are safe choices during pregnancy, as is benzoyl peroxide, an antibacterial agent that also dries the skin (4).
If topical preparations do not clear the skin, a woman’s provider may recommend oral treatment with antibiotics, such as erythromycin, that have not been associated with birth defects. If she is not planning pregnancy, treatment with oral contraceptives (which should not be used during pregnancy) also may be effective (4).
Are topical retinoids safe in pregnancy?
Topical retinoids are used to treat acne and sun-damaged skin. These include topical tretinoin (Retin A, Renova), adapalene (Differin) and tazarotene (Tazorac). Small amounts of these drugs may be absorbed through the skin into the bloodstream.
Studies suggest that topical retinoids do not cause birth defects (5, 6, 7). However, some questions about their safety remain due to a few reports of birth defects in babies of women who used these preparations during pregnancy (5, 6, 7). Until more is known about the safety of topical retinoids during pregnancy, it’s best for women who are pregnant or planning pregnancy to avoid them.
Are there other retinoids that are unsafe during pregnancy?
All oral retinoids pose a risk of birth defects similar to those caused by isotretinoin and should be avoided during pregnancy. As with isotretinoin, women should have a pregnancy test before starting these drugs and another each month. Women also should use two reliable forms of birth control during treatment and for varying periods of time after discontinuing use of these drugs.
A number of new retinoids are being tested for their effectiveness in treating and, in some cases, preventing various forms of cancer, including breast, ovarian and lung cancer. These drugs appear to cause cancer cells to behave like normal cells, possibly leading to remission of some cancers. If these drugs prove successful, women and their providers should pay careful attention to the risks for birth defects associated with use of these drugs.
Can high doses of vitamin A cause birth defects?
Vitamin A is crucial for normal fetal growth and development. However, too much of it may cause birth defects. A 1995 study found that women who took more than 10,000 IU (international units) of vitamin A daily in the first 2 months of pregnancy doubled their risk of having a baby with birth defects (11). The birth defects were similar to those seen in isotretinoin-exposed babies.
The FDA's current daily value (DV) for vitamin A is 5,000 IU (12). Other studies have suggested that doses less than 25,000 IU probably do not cause birth defects, but the lowest dose that can cause birth defects is unknown (13).
The body makes its own vitamin A, when needed, from vitamin A precursors, such as beta carotene. Beta carotene is found in yellow and green vegetables and some multivitamins. This form of the vitamin is believed to be completely safe during pregnancy.
However, much of the vitamin A we consume is the preformed vitamin which, in excessive amounts, can cause birth defects. Preformed vitamin A is found in many vitamin supplements and some foods, including meats (especially liver), eggs, dairy products and fortified breakfast cereals.
A pregnant woman should be sure that her multivitamin or prenatal supplement contains no more than 5,000 IU of preformed vitamin A, and she should not take any vitamin A supplements beyond that amount. She also should limit the amount of liver she eats.
What is the role of the March of Dimes in the study of retinoids?
The March of Dimes has supported research on isotretinoin and was instrumental in bringing to public attention the need for more stringent guidelines concerning its use. The March of Dimes continues to support research on the role of retinoids in both normal and abnormal fetal development, in order to better understand how these drugs may cause birth defects, with the ultimate goal of learning how to prevent them.
Last reviewed March 2010