European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Dec 2003
Comparative StudyEvaluation of the safety of bupropion (Zyban) for smoking cessation from experience gained in general practice use in England in 2000.
Bupropion (Zyban) is the first new pharmacological treatment for smoking cessation to be introduced since nicotine replacement therapy. In smoking cessation trials, it has been associated with minimal side effects. A range of suspected adverse drug reactions (ADRs) were reported via the spontaneous reporting system following its use in smoking cessation. ⋯ This study describes the safety profile of bupropion (Zyban) as used in the community; a small number of adverse events were reported that were not included on the SmPC. For many events, nicotine withdrawal was a confounding factor. SMR calculations did not provide evidence for a higher rate of mortality (either all-cause or condition-specific) in the PEM cohort relative to smokers from the CPS-II cohort in the USA. While reassuring, the SMR should be interpreted in context with results from other studies on bupropion when used for smoking cessation.