Bupropion and the risk of sudden death: a self-controlled case-series analysis using the Health Improvement Network

Richard Hubbard ^1*, Sarah A Lewis ¹, Joe West ¹, Christ Smith ¹, Christine Godfrey ², Liam Smeeth ³, Paddy Farrington ⁴ and John Britton ¹

¹ University of Nottingham, United Kingdom
² University of York, United Kingdom
³ London School of Hygiene and Tropical Medicine, United Kingdom
⁴ Open University, United Kingdom

^* To whom correspondence should be addressed. E-mail: richard.hubbard{at}nottingham.ac.uk.

Accepted 30 June 2005

Abstract

Background: Bupropion is an effective smoking cessation therapy but its use in the UK has been limited by concerns that it may increase the risk of sudden death.

Methods: We extracted data for all patients prescribed bupropion within the Health Improvement Network (a computerised general practice database), and used the self-controlled case-series method to estimate the relative incidence of death during the first 28 days of treatment. We also investigated the incidence of seizures, a recognised adverse effect of bupropion, during this period.

Results: 9,329 individuals had been prescribed bupropion; mean age 44 years, 48% male. The total person-time after the first prescription for bupropion was 17586 years, and during this time 121 people died. Two people died within the first 28 days of treatment, which was less than expected in comparison to the remaining observation period by an incidence ratio of 0.50 (95% confidence interval 0.12 to 2.05). Twenty eight people were recorded as having a total of 45 seizures; 23 before starting bupropion, 2 in the first 28 days of treatment and 20 at a later point. The relative incidence of seizures during the first 28 days of treatment was 3.62 (95% confidence interval 0.87 to 15.09); equivalent to one additional seizure per 6219 first time bupropion users.

Conclusions: This study suggests that bupropion use is probably associated with an increased risk of seizures, but we found no evidence to suggest that the drug is associated with an increased risk of sudden death.

Keywords: bupropion, case-series method, epidemiology, smoking cessation

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