Contraindications and Warnings
Contraindication in Pregnancy, Teratogenicity
- 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.
- Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, 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.
- 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 this agent, it 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 isotretinoin's teratogenicity and to minimize fetal exposure, it 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 PRECAUTIONS).
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Patient must have severe unresponsive recalcitrant nodular acne
- Compliant with instructions and contraception requirements
- Informed and signed consent
- Negative urine or serum pregnancy tests with a sensitivity of at least 50 mIU/mL as required (2 samples)
- Join Accutance survey and participate in patient education program
FDA and Industry Communications
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information