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