Other reported malformations included facial dysmorphism, microphthalmia, micrognathia, and cleft palate. Editorial Note: Although the total number of exposed, pregnant women is unknown, the consistency of the laboratory and human experiences with isotretinoin exposure during pregnancy provides sufficient evidence to conclude that the drug is a human teratogen.
The spectrum of malformations described among these infants exposed to isotretinoin resembles that found in the animal studies. The 10 infants referred to above have an unusual characteristic pattern of malformations not consistent with any known syndromes. The occurrence by chance of these defects in 10 infants of isotretinoin-exposed pregnant women is highly unlikely.
Among exposed pregnant women, the percentage of infants who will have malformations is unclear, since only five of the prospectively followed fetuses reached a viable gestational age. The large percentage of spontaneous abortions among the prospectively identified women suggests that fetotoxicity is a more common adverse outcome of exposure than malformation of a live infant.
As expected, birth defects were reported more frequently among exposed women after the outcomes of their pregnancies were determined than were spontaneous abortions and normal births. Since the drug was first marketed in the United States in September , the isotretinoin package insert has carried the following warning: "Because teratogenicity has been observed in animals given isotretinoin, patients who are pregnant or intend to become pregnant while undergoing treatment should not receive Accutane.
Women of childbearing potential should not be given Accutane unless an effective form of contraception is used, and they should be fully counseled on the potential risks to the fetus should they become pregnant while undergoing treatment.
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In This Topic. Isotretinoin is teratogenic at all therapeutic doses. Fetal malformation may occur with only a short period of exposure to isotretinoin during pregnancy 1 and has been reported after a single dose 3.
Isotretinoin embryopathy consists of craniofacial, cardiac, thymic and central nervous system malformations 4. Isotretinoin adversely affects 25—40 percent of fetuses exposed during embryogenesis ie, the first 10 weeks following conception 5.
For pregnancies that end in birth, the rate of malformations associated with isotretinoin exposure in utero has been reported as 11—30 percent, with most estimates at the upper end of this range 6. Fetal exposure to isotretinoin beyond the critical period of organogenesis can cause developmental delays and other central nervous system effects in approximately 40 percent of cases 4.
Despite the well-known teratogenic effects of isotretinoin, pregnancy exposures still occur. A review of the National Collections data indicated that during the period 1 July to 30 June , 39 live-born infants were potentially exposed to an oral retinoid during pregnancy or within 30 days of the estimated pregnancy start date. In 31 of these cases, isotretinoin was dispensed after the estimated pregnancy start date.
The patient did not want to terminate her pregnancy. The aim of this Critically Appraised Topic is to explore the literature to determine the chance of delivering a healthy child after fetal exposure to isotretinoin; the types of fetal malformations associated with it; and what monitoring should be performed.
Since introduction of the drug in , over pregnancies in the United States have been affected by fetal exposure to isotretinoin, 1 most resulting in spontaneous or elective abortions. We searched the Medline and EmBase databases from to March using the terms isotretinoin or Accutane or Roaccutane and pregnancy or birth defect. We found articles in the literature search and chose 2 case series 3 , 4 that prospectively identified and followed up pregnancies in which the fetus was exposed to isotretinoin for which abortion was not elected.
These 2 studies collected data from a combined total of pregnant women in the United States aged 14 years to older than 35 years whose fetuses were exposed to isotretinoin. 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.
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