Canada - The manufacturer of bupropion, Zyban®, indicated for smoking cessation treatment in conjunction with behavioural modification, and Wellbutrin®, indicated for symptomatic relief of depressive illness, has informed health professionals of important safety information.
The Canadian Adverse Reaction Monitoring Programme has received a total of 1127 reports of suspected adverse reactions associated with the use of bupropion. Of these, 682 were considered serious and 19 were fatal. 172 involved seizures/convulsions and 37 serum sickness. Cause and effect relationships have not been established or speculated in the vast majority of reports submitted. Not all suspected reactions are reported, and this information should not be used to estimate the incidence of adverse reactions.
As a consequence, physicians are requested to note important safety information concerning contraindications, concomitant use, risk of seizures and allergic reactions. A full description of these aspects is contained in the product monograph.
Reference: Letter to Health Professionals from Glaxo SmithKline Inc. date 3 July 2001 at http://www.gsk.com