He now has severe mental retardation and developmental delay and requires institutional care. Case 3: In September , a male infant of 27 weeks gestation was born to a woman who had taken isotretinoin during the second month of gestation. The infant had dysplastic external ears and hydrocephalus, which was treated with a ventriculo- peritoneal shunt. This abnormality is thought to be secondary to an intraventricular hemorrhage during the early neonatal period. Case 4: In January , a full-term male infant weighing 3, g was born with dysplastic ears and hearing loss.
His mother had been treated with isotretinoin during the first trimester of pregnancy. Isotretinoin was recognized as an animal teratogen before it was first marketed in September A statement to that effect was included in the package insert. In June , human teratogenicity was reported to FDA and to the public 2. Subsequent reports have documented a strong association between a characteristic group of birth defects and exposure to isotretinoin during the first weeks of gestation 3,4.
These defects include external ear malformations, cleft palate, micrognathia, conotruncal heart defects, ventricular septal defects, aortic-arch malformations, and certain brain malformations 3. In one prospective follow-up study, eight of 36 pregnancies that were exposed to isotretinoin resulted in spontaneous abortions during the first trimester; four resulted in live-born infants with at least one major malformation; one, in a malformed stillborn infant; and 23, in infants without major malformations 3.
This study found a relative risk of Etretinate also carries Category X labeling. Measurable serum concentrations of this drug have been documented more than 2 years after cessation of therapy 5 , and the risk of teratogenicity may extend for an indefinite period of time after therapy 6.
Isotretinoin embryopathy is a preventable syndrome, and the number of infants born with these problems can be reduced by following the guidelines developed cooperatively by FDA and the manufacturer, Hoffmann-La Roche, Inc.
Isotretinoin is a kind of prescription medicine called an oral retinoid. Taking isotretinoin or other oral retinoids during pregnancy can cause serious birth defects in babies. Isotretinoin is a prescription medicine used to treat a severe type of acne called nodular acne. Nodular acne causes large, painful lumps in the skin. Isotretinoin is a kind of medicine called an oral retinoid. Retinoids are man-made forms of vitamin A used to treat certain skin conditions and blood cancers.
Oral means that you take it by mouth. Taking isotretinoin or other oral retinoids during pregnancy can cause serious problems for your baby. The FDA is the government agency that checks the safety of food and medicine in this country. Anyone—both women and men—who plans to take isotretinoin must register with iPLEDGE and follow strict rules about taking the medicine.
And you can get it only at registered pharmacies. Men who take isotretinoin can have a very small amount of it in their semen fluid that contains sperm.
Use a male latex condom every time you have sex to help prevent pregnancy while your partner is taking isotretinoin and for 1 month after he stops taking it. If you get pregnant while taking isotretinoin or within 1 month after taking isotretinoin, your provider must report it to the company that makes isotretinoin, iPLEDGE and the FDA.
Other oral retinoids can cause birth defects similar to those caused by isotretinoin. Topical retinoids are medicines you put directly on your skin. Topical retinoids that are used to treat acne include:.
Learn how to keep breast milk safe and healthy. Retinoids are man-made forms of vitamin A. Your baby needs vitamin A for healthy growth and development during pregnancy. But too much may cause birth defects.
Your body makes its own vitamin A when you eat certain yellow and green vegetables. This form of vitamin A is safe during pregnancy. Getting too much preformed vitamin A can cause birth defects. Preformed vitamin A is found in foods like meat especially liver , fish and dairy foods. Talk to your provider to make sure you get the right amount of vitamin A during pregnancy.
Most women can get the right amount from healthy eating and their prenatal vitamin. Get expert tips and resources from March of Dimes and CDC to increase your chance of having a healthy, fully-term pregnancy and baby. BabyLiveAdvice lets you tap into a virtual network of nurses, midwives, lactation consultants, nutritionists and health professionals for support when you need it most. Herein, we found a case of ear malformation occurring after 1 month of isotretinoin discontinuation. We, therefore, suggest that a new guideline recommending a longer duration of isotretinoin discontinuation before conception and further studies of pharmacokinetics isotreinoin are needed.
National Center for Biotechnology Information , U. Journal List Yonsei Med J v. Yonsei Med J. Published online Jun Find articles by Soon Min Lee.
Find articles by He Min Kim. Find articles by Jun Seok Lee. Find articles by Choon Sik Yoon. Find articles by Min Soo Park. Find articles by Kook In Park. Find articles by Ran Namgung. Find articles by Chul Lee. Author information Article notes Copyright and License information Disclaimer. Corresponding author. Corresponding author: Dr. Tel: , Fax: , ca. This article has been cited by other articles in PMC. The main abnormalities found in isotretinoin embryopathy are craniofacial, central nervous system, cardiovascular, and thymic.
Craniofacial: ear defects, dysmorphism, cleft palate, depressed nasal bridge, hypertelorism;. Central nervous system: hydrocephalus, microcephaly, facial nerve palsy, cortical and cerebellar defects;. Cardiovascular: Fallot's tetralogy, transposition of great vessels, septal defects, aortic arch hypoplasia;.
In addition, fetal exposure to isotretinoin is associated with high risk of adverse outcome with respect to mental functioning.
The National Teratology Information Service recommends that women who wish to continue their pregnancy after fetal exposure to isotretinoin should have alpha-fetoprotein testing at 16 to 19 weeks' gestation and undergo a targeted ultrasound scan and echocardiography at 20 to 21 weeks' gestation.
The high rate of fetal exposure to isotretinoin and its serious teratogenicity are clearly illustrated. However, it is also important that dermatologists prevent pregnant women from taking the medication document proof of no pregnancy and prevent women who are taking it from getting pregnant use of 2 forms of birth control.
There is no dose of oral isotretinoin that is safe for use in pregnant women 3 , 12 and, consequently, there are no published studies of women who took isotretinoin throughout pregnancy. Therefore, information about safety must be obtained from studies in which isotretinoin was taken for acne during some portion of pregnancy. Reported outcomes of retrospectively and prospectively ascertained cases differ considerably. Published prospective outcome data are available for only a small proportion of pregnancies in which the fetus was exposed to isotretinoin because most of these pregnancies are not reported in the literature.
The level of fetal exposure to isotretinoin varies from pregnancy to pregnancy so it is possible that isotretinoin-related problems may be higher for women who continue taking isotretinoin for a longer duration before discovering that they are pregnant. However, there is insufficient data to address this issue. There is little information about the timing of spontaneous abortions, either in weeks or trimesters.
There is little follow-up data on infants with no gross malformation to determine the risk of developmental disabilities later in life.
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