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The Pharmaceutical Journal
Vol 269 No 7209 p149
3 August 2002

Related websites
Medicines Control Agency (www.mca.gov.uk)
European Agency for the Evaluation of Medicinal Products (EMEA) (www.emea.eu.int)
Zyban (www.zyban.co.uk)

Zyban safety update continues to reveal only recognised reactions

The latest safety update for bupropion (Zyban) from the Medicines Control Agency shows that up to 24 July, a total of 7,630 reports of suspected adverse reactions have been received via the yellow card scheme in the United Kingdom. All are recognised reactions and are listed in the summary of product characteristics for bupropion.

Reports of adverse reactions with a fatal outcome have risen to a total of 60 but the MCA points out that in most of these cases an underlying condition could have been responsible. "Cardiovascular disorders, including myocardial infarction, and cerebrovascular disorders, including stroke, were the reported causes of death in 70 per cent of these reports," the safety update states. It adds that in 14 of the reports, the individual was not taking bupropion at the time of death.

EMEA review A review of bupropion-containing medicinal products by the European Agency for the Evaluation of Medicinal Products (EMEA) has concluded that the balance of risks and benefits of bupropion as an aid to smoking cessation remains favourable. The EMEA recommends that bupropion should be used in accordance with smoking cessation guidelines. The review was conducted following a referral by Germany in February.