WHO Pharmaceuticals Newsletter 2003, No. 04
(2003; 13 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentABACAVIR, LAMIVUDINE, TENOFOVIR - Virologic non-response in HIV with combination therapy
View the documentACETYL-SALICYLIC ACID (PAEDIATRIC) - OTC withdrawal
View the documentACETYL-SALICYLIC ACID, PARACETAMOL, IRON - New packaging standards for improving child resistance
View the documentBENZ-BROMARONE - Withdrawn due to reports of liver damage
View the documentEZETIMIBE - Labelling update regarding hypersensitivity reactions
View the documentLEFLUNOMIDE - Explicit liver function monitoring directions added to label
View the documentPAROXETINE - Unfavourable risk benefit ratio in children and adolescents
View the documentSALMETEROL - Risk of life-threatening asthma episodes
View the documentSOMATROPIN (rDNA ORIGIN) - Reports of fatalities in paediatric patients with Prader-Willi syndrome
View the documentTIROFIBAN - Advice against off-label use
View the documentTOPIRAMATE - Risk of oligohidrosis and hyperthermia
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS IN THE NEWS
 

TOPIRAMATE - Risk of oligohidrosis and hyperthermia

USA, Canada. Ortho-McNeil Pharmaceutical Inc in the USA and Janssen-Ortho Inc in Canada are warning healthcare professionals about rare reports, primarily in children, of oligohidrosis (decreased sweating) and hyperthermia in patients treated with topiramate (Topamax). Most cases occurred in association with exposure to elevated temperatures and/or energetic activity. The prescribing information for topiramate (Topamax) has been updated to reflect these reports. Oligohidrosis and hyperthermia may have potentially serious sequelae and may be preventable by prompt recognition of symptoms and appropriate treatment. Patients on topiramate therapy should be closely monitored for signs of decreased sweating and increased body temperature, and when topiramate is prescribed with other drugs such as carbonic anhydrase inhibitors and anticholinergics that can predispose patients to heat-related disorders.

Reports in WHO-file:

Sweating decreased 9, hyperpyrexia 3, hyperpyrexia malignant 1

Reference:

1. ‘Dear Healthcare Professional’ letter from Ortho-McNeil, 09 Jul 2003. Available from URL: http://www.fda.gov

2. ‘Dear Healthcare Professional’ letter from Janssen-Ortho Inc, 11 Jul 2003. Available from URL: http://www.hc-sc.gc.ca

 

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