WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentACETYLSALICYLIC ACID - MHRA confirms labelling change
View the documentACITRETIN - Warnings of depression added to label
View the documentASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
View the documentCAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
View the documentDIETARY SUPPLEMENTS - Withdrawal of two products due to presence of sildenafil
View the documentHUA FO - Presence of tadalafil
View the documentIODINE - Some products contain more than the RDA
View the documentLEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
View the documentLINDANE - Additional warnings and medication guide added to label
View the documentNEFAZODONE - Regulatory status update
View the documentNIMESULIDE - Paediatric preparations banned in Bangladesh
View the documentPERGOLIDE MESYLATE - Risk of cardiac valvulopathy
View the documentREPAGLINIDE - Contraindicated with gemfibrozil
View the documentRISPERIDONE - Prescribing information updated to reflect cardiovascular adverse events
View the documentTELITHROMYCIN - Aggravation of myasthenia gravis
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsCURRENT CONCERNS
Open this folder and view contentsDRUGS OF INTEREST
Open this folder and view contentsFEATURE
 

ACITRETIN - Warnings of depression added to label

US. Warnings of depression, aggressive feelings and thoughts of self-harm have been added to the label of acitretin (Soriatane), a product indicated in the treatment of psoriasis. These additions follow reports linking such observations with the use of the product. However, a definite causality has not been established since other factors may have contributed to some of these events. Warnings over the drug’s use in pregnancy have also been enhanced. Female patients are now required to have two negative pregnancy tests before start of therapy and must also simultaneously take two effective forms of birth control. Additionally, they must sign an agreement that they are not pregnant at start of therapy, must not get pregnant during therapy, or for three years after discontinuing treatment.

Reference:
Pharma Times News Online, 9 May 2003. Available from URL: http://www.pharmatimes.co.uk

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