The Pharmaceutical Journal Vol 267 No 7169 p495-500
13 October 2001

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Latest reports of adverse events associated with amfebutamone

A safety update for amfebutamone (bupropion, Zyban), which gives details of suspected adverse events associated with the drug, has been issued by the Medicines Control Agency.

The update says that, as of 24 September, the MCA had received 6,570 reports of suspected adverse reactions via the “yellow card” scheme, all of which were listed on the drug’s summary of product characteristics. The suspected adverse reactions most commonly reported were insomnia (n=874), urticaria (859), rashes (755), headache (642) and dizziness (633).

The MCA says that amfebutamone is associated with a dose-related risk of seizure, with an estimated incidence of approximately 0.1 per cent. There have been 160 reports in the United Kingdom of seizures suspected to be associated with the drug but about half of the patients involved either had a history of seizure and/or predisposing risk factors.

The update says that 51 of the reports of suspected adverse reactions had been fatal. In these cases, the contribution of amfebutamone had not been proven and, in most cases, there might have been alternative causes.

The MCA says that it is important to remember that suspected reactions are not necessarily caused by amfebutamone and could relate to other factors, such as nicotine withdrawal, other illnesses or concurrent medication. It asks pharmacists and physicians to continue to send in reports of suspected adverse reactions.

The safety update can be found on the MCA’s website (www.mca.gov.uk).

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