WARNING: CAUSES BIRTH DEFECTS
Pregnancy Category X
There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Absorica™ in any amount, even for short periods of time [See WARNINGS AND PRECAUTIONS and Use in Specific Populations].
Potentially any fetus exposed during pregnancy can be affected [See Use in Specific Populations].
Birth defects which have been documented following isotretinoin 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 [See Use in Specific Populations].
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 abnormalities previously noted [See Use in Specific Populations].
If pregnancy does occur during the treatment of a female patient who is taking Absorica™, Absorica™ must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling [See Use in Specific Populations].
Special Prescribing Requirements
Because of the risk of teratogenicity and to minimize fetal exposure, Absorica™ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE™. Under the Absorica™ REMS, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program [see WARNINGS AND PRECAUTIONS].
Absorica™ (isotretinoin), a retinoid, is available in 10 mg, 20 mg, 30 mg and 40 mg hard gelatin capsules for oral administration. Each capsule contains isotretinoin, stearoyl macrogolglycerides, soybean oil, sorbitan monooleate and propyl gallate. Gelatin capsules contain the following dye systems: 10 mg – iron oxide (yellow) and titanium dioxide; 20 mg – iron oxide (red) and titanium dioxide; 30 mg – iron oxide (yellow, red and black) and titanium dioxide; and 40 mg – iron oxide (yellow, red and black) and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:
Last reviewed on RxList: 6/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Absorica Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.