WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Close this folderRegulatory actions
View the documentAluminium in total parenteral nutrition - labelling requirements & warning
View the documentAstemizole - warning concerning cardiovascular adverse events
View the documentBromfenac - warning label: liver damage
View the documentCarbamazepine - warning concerning precipitation
View the documentChlormezanone - withdrawn
View the documentCounterfeit drugs - warning to the public
View the documentDietary supplement "Sleeping Buddha" - warning concerning estazolam content
View the documentFenfluramine - withdrawn
View the documentHuman dura mater (freeze-dried) - restrictive measures
View the documentIsotretinoin - psychiatric adverse effects
View the documentPyrithione zinc (Skin-CapR) - withdrawn
View the documentSertindole - approval application withdrawn
View the documentTerfenadine - additional drug interactions
View the documentTerfenadine - withdrawn following approval of fexofenadine
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
View the documentRecent approvals
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary medicine
 

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.

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