Fifty-seven deaths put anti-smoking drug under spotlight
LONDON, Jan 18 AFP|Published: Friday January 18, 10:06 PM
A total of 57 people in Britain have died after suspected adverse reactions to the anti-smoking drug Zyban, according new to British government figures.
The regulatory Medicines Control Agency (MCA) stressed that there was no proof Zyban had contributed to the deaths, and that in most case the person's underlying nicotine-dependent condition could provide a reason.
In January last year, the number of fatalities reported after taking the GlaxoSmithKline drug was 18. Zyban was licensed in Britain in June 2000.
Half a million patients in the UK are estimated to have received the drug. In a statement, the MCA said there had been a total of 6,975 reports of suspected adverse reactions by January 10.
Of those, 168 were for reported seizures. Others include insomnia, rashes, headache, nausea, vomiting and depression.
"There have been 57 reports of suspected adverse reactions to Zyban which have resulted in a fatal outcome," the MCA said in a safety update on its website.
"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."
An MCA spokesman stressed that in comparing Zyban with other medicines, the proportion of Zyban reports that had fatal outcomes was much lower, less than one per cent.
"As with all new drugs, the safety of Zyban remains under close review," the MCA statement went on.
GlaxoSmithKline, Europe's biggest drug maker, said the treatment posed no increased danger to smokers.
A spokesman said: "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."
The spokesman pointed out that smoking-related disease killed 320 people a day in Britain.
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