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Generic Name: isotretinoin, dosage Form: capsule, liquid filled, medically reviewed on February 1, 2018, show On This Page. View All, causes birth, defects, dO NOT GET, pregnant. Contraindications AND warnings, accutane must not be used by female patients who are accutane warnings or accutane warnings may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane 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. Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, accutane warnings ears, skull, central nervous system, cardiovascular accutane warnings 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. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals eye abnormalities (including microphthalmia facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements, because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called ipledge. Accutane must only be prescribed by prescribers who are registered and activated with the ipledge program. Accutane must only be dispensed by a pharmacy registered and activated with ipledge, and must only be dispensed to patients who are registered and meet all the requirements of ipledge (see. Table 1 Monthly Required ipledge Interactions. Female Patients of Childbearing Potential, male Patients, And Female Patients Not of Childbearing Potential. Prescriber, confirms patient counseling, x X, enters the 2 contraception methods chosen by the patient. X, enters pregnancy test results X patient, answers educational questions before every prescription. X, enters 2 forms of contraception X pharmacist, contacts system to get an authorization. X X, the Accutane brand name has been discontinued in the.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available. Accutane Description, isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl with the following dye systems: 10 mg iron oxide (red) and titanium dioxide; 20 mg FD C Red. 3, FD C Blue. 1, and titanium dioxide; 40 mg FD C Yellow. 6, D C Yellow. 10, and titanium dioxide.