(1998; 18 pages)
Isotretinoin - psychiatric adverse effects
United States of America. The Food and Drug Administration has informed consumers and health care providers of isolated reports of depression and psychosis that have been received together with rare reports of suicidal thoughts and actions associated with the prescription anti-acne drug, isotretinoin (AccutaneR: Roche).
In view of the complex nature of depression and suicidal conditions, the new label information will advise health care providers that merely discontinuing the drug may be insufficient to remedy these adverse events, and that further evaluation may be needed.
References: FDA Talk Paper T98-9, dated 25 February 1998.