The number of people who have died after taking the anti-smoking drug Zyban has more than tripled in a year, official figures show.

By January 10, 57 people had died following suspected adverse reactions to the drug, compared to 18 the same time last year, the Medicines Control Agency (MCA) found. But the MCA said a direct link between the drug, which was launched in June 2000, and the deaths was unproven. And anti-smoking campaigners said most of the deaths would have occurred anyway. Data on adverse reactions to the drug was reported by doctors, dentists, pharmacists, coroners and pharmaceutical companies under the government's "yellow card" scheme. In a notice published on its website, the MCA said: "There have been 57 reports of suspected adverse reactions to Zyban which have resulted in a fatal outcome. "The contribution of Zyban to these fatal cases is unproven and in the majority of cases the individual's underlying condition may provide an alternative explanation. "In 14 of these reports the individual was not taking Zyban at the time of their death." Raised awareness The MCA has received 6,975 reports of suspected adverse reactions to Zyban, including insomnia, rashes, headache, nausea, vomiting and depression. Of those, 168 patients suffered seizures suspected as being associated with Zyban. A spokesman for the MCA said the figures were an update to keep people aware of the position. "As with all new drugs, the safety of Zyban remains under close review." He added: "Comparing Zyban with other medicines, the proportion of Zyban reports that have fatal outcomes is much lower - less than 1%." Doctors and pharmacists will be asked to continue reporting all suspected adverse reactions to the MCA and the Committee on Safety of Medicines, an expert advisory group. A spokesman for pharmaceutical giant GlaxoSmithKline, which makes the drug, said: "Smoking-related disease claims 320 lives a day in the UK. "There is currently no reason to believe that patients taking Zyban have an increased risk of death. "There is no proven link with deaths and the medicine is used in patients who are already at risk because of smoking. Clive Bates, of Action on Smoking and Health, told BBC News Online said: "Most of these people would have died anyway. "It's important not to confuse deaths that happen while using the drug with deaths that happen because of using the drug." He added that over 400,000 people have used Zyban.

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