Isotretinoin has demonstrated efficacy in a wide range of disorders. The beneficial effects of the drug, however, are limited by its adverse effects on the bone. Children exposed to high doses are at risk for premature epiphyseal closure, while adults on long-term therapy have an increased tendency to develop hyperstosis and other changes of the bone.
– : J Am Acad Dermatol 2001 Nov;45(5):S176-82 — Isotretinoin effects on bone. — DiGiovanna JJ.



The most important issue is that of congenital defects, which has resulted in new pregnancy prevention policies and programs implemented by the manufacturer. The medication can cause birth defects and fetal death. A relatively new concern is that of depression associated with isotretinoin use, also resulting in new policies placed by the manufacturer and the FDA.
– Semin Cutan Med Surg 2001 Sep;20(3):166-83 — Safety issues in isotretinoin therapy. — Hanson N, Leachman S.



Vitamin A and synthetic retinoids have recently been used increasingly in a variety of health related concerns. Hepatic toxicity is an uncommon but serious side-effect of several Vitamin A derivatives which may lead to cirrhosis. This review will focus on the clinical and pathologic findings of hepatic involvement in chronic hypervitaminosis A and on the evidence concerning the potential hepatotoxicity of currently available synthetic retinoids.
– J Gastroenterol Hepatol 1990 May-Jun;5(3):334-42 — Hepatic toxicity of vitamin A and synthetic retinoids. — Fallon MB, Boyer JL.



Aggressive and/or violent behaviors have been added to the list of events that Accutane may cause, based on post-marketing safety reports. No mechanism of action has been established for these events. A new table has been added to clarify those circumstances where pregnancy tests and Accutane Qualification Stickers are applicable. Information specific to pediatric patients has been added based on the results of recent studies conducted in this patient population. A statement has been added regarding the long-term use of Accutane advising that Accutane be given at the recommended doses for no longer than the recommended duration. Prescribers were advised to exercise caution when systemic corticosteroids or phenytoin are used with Accutane.

– Accutane (isotretinoin) — FDA MedWatch — http://www.fda.gov/medwatch/safety/2002/safety02.htm