WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) Ver el documento en el formato PDF
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Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoACETYLSALICYLIC ACID - MHRA confirms labelling change
Ver el documentoACITRETIN - Warnings of depression added to label
Ver el documentoASTEMIZOLE - Withdrawn due to life-threatening ventricular arrhythmias
Ver el documentoCAMELIA SINENSIS - Ethanolic extract products withdrawn due to hepatotoxicity
Ver el documentoDIETARY SUPPLEMENTS - Withdrawal of two products due to presence of sildenafil
Ver el documentoHUA FO - Presence of tadalafil
Ver el documentoIODINE - Some products contain more than the RDA
Ver el documentoLEVODOPA/CARBIDOPA - New warning about somnolence and sudden onset sleep
Ver el documentoLINDANE - Additional warnings and medication guide added to label
Ver el documentoNEFAZODONE - Regulatory status update
Ver el documentoNIMESULIDE - Paediatric preparations banned in Bangladesh
Ver el documentoPERGOLIDE MESYLATE - Risk of cardiac valvulopathy
Ver el documentoREPAGLINIDE - Contraindicated with gemfibrozil
Ver el documentoRISPERIDONE - Prescribing information updated to reflect cardiovascular adverse events
Ver el documentoTELITHROMYCIN - Aggravation of myasthenia gravis
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Abrir esta carpeta y ver su contenidoCURRENT CONCERNS
Abrir esta carpeta y ver su contenidoDRUGS OF INTEREST
Abrir esta carpeta y ver su contenidoFEATURE

ACETYLSALICYLIC ACID - MHRA confirms labelling change

UK. In a follow-up of the Medicines Control Agency’s Statement on acetylsalicylic acid (Aspirin) use (WHO Pharmaceuticals Newsletter No. 4, 2002), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has posted, on its website, a notification that from 1 Oct 2003 all acetylsalicylic acid-containing products will be required to include the following statutory label warning: "Do not give to children under 16 years, unless on the advice of a doctor". This requirement follows an 8-week consultation process after which the Medicines Commission endorsed the advice of the UK Committee on Safety of Medicines that the warning was required. Professor Breckenridge, chairman of the Agency pointed out that there are plenty of alternative analgesic products for this age group not associated with Reye’s Syndrome and that "there is simply no need to expose those under 16 to the risk, however small".

Medicines and Healthcare products Regulatory Agency. Internet Document, 4 Apr 2003. Available from URL: http://www.mhra.gov.uk

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