The number of people who have died after taking the anti-smoking drug Zyban has more than tripled in a year, according to British government figures published today.
A total of 57 patients had died by January 10 this year following suspected adverse reactions to Zyban, the British Medicines Control Agency (MCA) found.
The same time last year, the figure for the GlaxoSmithKline drug was 18, the regulatory body said. The drug was first licensed in June 2000.
However, the MCA was keen to stress that the link between the medicine and deaths are unproven.
A safety update posted on its website 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.’’
And an MCA spokesman added: ‘‘Comparing Zyban with other medicines, the proportion of Zyban reports that have fatal outcomes is much lower less than 1%.’’
In total, the MCA has received 6,975 reports of suspected adverse reactions to Zyban, including insomnia, rashes, headache, nausea, vomiting and depression.
This includes 168 patients who suffered seizures suspected as being associated with Zyban, said the MCA.
The MCA spokesman said the figures were an update to keep people aware of the position.
A spokesman said: ‘‘As with all new drugs, the safety of Zyban remains under close review.
‘‘Doctors and pharmacists are asked to continue to report all suspected adverse reactions to the MCA/CSM (Committee on Safety of Medicines, an expert advisory group).’’
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.
‘‘Smoking-related disease claims 320 lives a day in the UK.’’
The figures were collected under the Government’s ‘‘yellow card’’ scheme, under which doctors, dentists, pharmacists, coroners and pharmaceutical companies are required to log any problems with drugs.
According to the MCA, around 500,000 people in the UK are estimated to have taken Zyban.
GlaxoSmithKline shares were 3.5% down at 1,640 pence after the news, a spokesman for the company said.