WHO Pharmaceuticals Newsletter 2004, No. 04
(2004; 14 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentALOSETRON - Risk management plan to remain in place
View the documentANTIDEPRESSANTS - Health Canadaendorsed safety information
View the documentBUPROPION - Labelling updated to include class warning
View the documentCLOZAPINE - Labelling to include updated patient safety registry information
View the documentDEXTROPROPOXYPHENE/PARACETAMOL - Prescribing reminder
View the documentDOMPERIDONE - Not to be used to increase milk production in women
View the documentLEFLUNOMIDE - Update on interstitial lung disease
View the documentROSUVASTATIN - Higher dose and predisposing factors linked with rhabdomyolysis
View the documentSULPHUR HEXAFLUORIDE - Use in echocardiography suspended
Open this folder and view contentsSAFETY OF MEDICINES
View the documentANNOUNCEMENT
 

BUPROPION - Labelling updated to include class warning

Canada. Following discussions with Health Canada, Biovail Pharmaceuticals has advised of bupropion-associated behavioural and emotional changes in a "Dear Healthcare Professional" letter. Bupropion is marketed in Canada as the antidepressant Wellbutrin SR and the smoking cessation drug Zyban, and a Class warning regarding behavioural and emotional changes, including risk of self-harm, has been added to the labelling of both products. This warning applies to both paediatric and adult patients, although neither of these products is indicated for use in patients aged <18 years.

Reference:

"Dear Healthcare Professional" letter from Bioavail Pharmaceuticals, 8 June 2004. Available on the Internet at www.hc-sc.gc.ca

to previous section to next section
 

Last updated: May 3, 2013