Isotretinoin Pregnancy and Breastfeeding Warnings

Isotretinoin is also known as: Absorica, Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane

Isotretinoin Pregnancy Warnings

Isotretinoin has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy; however, isotretinoin is known to be teratogenic to humans. The birth defects documented following exposure to isotretinoin include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Isotretinoin use is considered contraindicated during pregnancy.

Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. The birth defects documented following exposure to isotretinoin include abnormalities of the face, eyes, ears, skull, central nervous system (CNS), cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. External abnormalities have included skull abnormality, ear abnormalities, eye abnormalities (including microphthalmia), facial dysmorphia, and cleft palate. Internal abnormalities have included CNS abnormalities, cardiovascular abnormalities, thymus gland abnormality, and parathyroid hormone deficiency. In some cases death has occurred with some of the abnormalities previously mentioned. If pregnancy occurs during the course of treatment of a female, the drug must be discontinued immediately and she should be referred to an obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling. In an FDA Public Health Advisory, the FDA announced the approval of the Strengthened Risk Management Program for Isotretinoin. Because of the high teratogenicity of isotretinoin and to minimize fetal exposure, isotretinoin is available only through a special restricted distribution program called iPLEDGE (TM). Prescribers, pharmacies, and wholesalers must be registered and activated with the iPLEDGE program in order to prescribe, dispense, or distribute isotretinoin. Isotretinoin must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. This registration process ensures that prescribers, pharmacists, and patients agree to assume specific responsibilities to ensure that patients do not become pregnant while taking isotretinoin and do not get prescribed the medicine if they are pregnant. Further details on iPLEDGE are available at www.ipledgeprogram.com. Isotretinoin was first marketed in the US in September of 1982. In July of 1983, the first reports of malformed infants were received by the manufacturer prompting a "Dear Doctor" letter reiterating the dangers of isotretinoin use in pregnancy. Despite further educational efforts by the manufacturer, unintentional exposures of pregnant women to isotretinoin continue to occur. Cardiovascular abnormalities observed have included interrupted aortic arch, ventricular septal defect, atrial septal defect, transposition of the great vessels, and Tetralogy of Fallot. Ear abnormalities have included anotia, micropinna, and small or absent external auditory canals. Central nervous system abnormalities have included cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, and cranial nerve deficit. Craniofacial abnormalities have frequently included occipital vaulting, and/or a sharply sloping, narrow forehead, wide-spaced eyes, small chin, and flat, depressed nasal bridge. Dai et al. 1992 reported 433 first-trimester exposures to isotretinoin of which pregnancy outcomes was known in 409 cases. Elective abortion was performed in 222 (54%) of these pregnancies and 29 (7%) ended in spontaneous abortions. Of 151 births, 72 (48%) were normal and 71 (47%) had congenital malformations. Malformations and spontaneous abortions occurred in women whose exposure to isotretinoin had been less than one week. Limb reduction defects have been reported in at least two infants, along with other multiple malformations characteristic to isotretinoin exposure. One infant with isotretinoin embryopathy, including thymic hypoplasia, demonstrated progressive attrition of T cells following her birth. She died after several bouts with pneumonia. It is suggested that isotretinoin may provide insult to the immune system as well as other teratogenic effects. Another infant with isotretinoin embryopathy and bilateral major ear deformities also demonstrated significant bilateral conductive hearing loss and left sided sensorineural loss. Peripheral and central vestibular dysfunction was also present. Any suspected fetal exposure during or 1 month after isotretinoin therapy must be reported at once to the FDA via the MedWatch number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the Internet (www.ipledgeprogram.com).

Isotretinoin Breastfeeding Warnings

There are no data on the excretion of isotretinoin into human milk. Because of the potential for adverse effects in nursing infants, breast-feeding is considered contraindicated by the manufacturer.

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