Accutance is a prescription drug developed, manufactured and marketed by Roche Pharmaceuticals that contains isotretinoin and is indicated for treatment of severe recalcitrant nodular acne, consisting of many cysts on the skin. The Food and Drug Administration approved Accutane in 1982. Isotretinoin is a retinoid, similar in chemical structure to vitamin A. Accutane inhibits excess secretion of sebum, an oily substance that protects the skin, from the sebaceous gland in the skin where acne cysts develop.
Medical Condition
Acne is a skin disease that occurs in all ages. Recalcitrant nodular acne, also called cystic acne, is a severe form of acne that occurs when oil and dead skin cells build up deep within the sebaceous glands and form lesions, or boil-like infections that rupture. If left untreated, cystic acne can scar the skin.
Benefits
Research conducted by F. Ghalamkarpour, and published in the Archives of Iranian Medicine in 2006, demonstrated that 65 percent of acne patients treated with isotretonoin were completely cured, with a rise in triglycerides as the only significant adverse reaction noted in the study, despite the potential for other adverse reactions. The research indicates that isotretinoin has favorable results and a low incidence of adverse effects in treatment of carefully-selected patients with acne.
Dosage
Accutane is supplied in soft gelatin capsules in dosages of 10 mg, 20 mg and 40 mg of isotetinoin. The recommended dose for Accutane is 0.5 to 1.0 mg per kg of body weight per day, given in two divided doses with meals, for 15 to 20 weeks. Dosages can be adjusted during the course of treatment, and treatment can stop if the number of cysts reduces by more than 70 percent. Long term use has not been studied and is not recommended.
Warnings
The Accutane product label warns users the drug should not be taken by women who are or may become pregnant because of the extremely high risk of severe birth defects that can occur with any dosage level, even if taken for a short period. Any fetus exposed to Accutane can be affected. Birth defects documented from Accutane exposure include abnormalities of the nervous and cardiovascular systems, thymus and parathyroid glands, skull, face, eyes and ears. There is also an increased risk of spontaneous abortion and premature birth.
The product label also warns Accutane can cause psychiatric disorders including depression, psychosis and in rare cases, suicide and aggressive and violent behavior. Research by Y. Barak, published in International Clinical Psychopharmacology in 2005, discovered that Accutane is associated with development of manic psychosis.
Adverse Reactions
Accutane has several adverse reactions, according to the product label. Serious skin reactions to Accutane have been reported, such as death to skin cells that could require hospitalization and death. Some patients can develop inflammation of the pancreas, elevation of fat and cholesterol in the blood, hearing impairment, inflammation of the liver and inflammatory bowel disease. Accutane can also cause vision impairment, particularly affecting the cornea and decreased ability to see at night.
Considerations
Due to potential risks, Accutane is reserved for patients with severe acne who are unresponsive to other drugs.
References
- Roche Pharmaceuticals: Accutane Prescribing Information
- Food and Drug administration: FDA Approved Drug Products
- MayoClinic.com: Acne
- Archives of Iranian Medicine; "Isotretinoin in Treatment of Acne"; Ghalamkarpour, F.; Jul 2006
- International Clinical Psychopharmacology; "Affective Psychosis Following Accutane Treatment"; Barak, Y.; Jan 2005
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