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Antismoking drug comes under scrutiny after deaths

BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7284.452/b (Published 24 February 2001) Cite this as: BMJ 2001;322:452
  1. Roger Dobson
  1. Abergavenny

    The manufacturer of the antismoking drug amfebutamone (Zyban), GlaxoSmithKline, has insisted that no evidence exists of an increased risk of death with its use, after 18 deaths were linked with suspected adverse drug reactions. The Medicines Control Agency said that the contribution of amfebutamone to the deaths is unknown.

    “It should be noted that patients may be required to stop smoking because of underlying diseases and these may well explain some of the reported deaths in patients taking Zyban,” said a spokeswoman for the agency.

    She added, “It is important to note that suspected reactions are not necessarily caused by the drug and may relate to other factors such as nicotine withdrawal, other illnesses, or other medicines taken concurrently.”

    Latest figures show that in addition to the 18 deaths there have been 3457 cases of adverse reactions. Most of these are minor—the most common being dry mouth, headache, and insomnia—but there have also been some involving seizures. About 270000 patients in the United Kingdom have been prescribed the drug, and amfebutamone has been used by 22 million people worldwide.

    The drug is described by GlaxoSmithKline as the first non-nicotine pharmacological treatment licensed for smoking cessation.

    “It is important to note that suspected reports are not necessarily caused by the drug and may relate to other factors such as other illnesses, other medicines or more importantly smoking itself,” said a spokeswoman for GlaxoSmithKline. “There is no evidence of an increased risk of death associated with the use of this medicine. It is, however, well doc umented that 1 in 4 smokers will die in middle age from a smoking related disease.”

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