UK Says 57 Die After Taking Anti-Smoking Drug

By Richard Woodman

LONDON (Reuters) - Fifty-seven people have died in Britain after taking the anti-smoking drug Zyban, but a link between the medicine and the deaths is unproven, the country's Medicines Control Agency said on Thursday.

In a safety update posted on its Web site (http://www.mca.gov.uk/), the British regulatory body said it had received thousands of reports of suspected adverse reactions to the GlaxoSmithKline drug.

``There have been 57 reports of suspected adverse reaction to Zyban which had 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,'' it said.

In 14 of those cases, the patients had stopped taking Zyban at the time of death, it added.

An MCA spokesman said the figures were an update to keep people aware of the position.

``Our position is that we are keeping an eye on the drug at the moment,'' he told Reuters.

GlaxoSmithKline, Europe's biggest drugmaker, said the treatment posed no increased danger to smokers. ``There is currently no reason to believe that patients taking Zyban have an increased risk of death. The medicine is used in patients who are already at risk because of smoking. Smoking-related disease claims 320 lives a day.''

GlaxoSmithKline shares were 2.12 percent down at 1,662 pence after the news, compared with 1,677 pence earlier in the day.

RISK OF SEIZURES

Zyban, which was originally licensed for treating depression, has been under close surveillance since it was re-launched in 2000 to help people stop smoking.

An estimated 500,000 people so far have taken the drug in Britain where it accounts for a third of all reported adverse drug reactions.

The MCA reminded doctors that Zyban is associated with a risk of seizures. To reduce this risk, the drug should not be prescribed to patients with a history of seizures, bulimia, anorexia nervosa, or those experiencing abrupt withdrawal from alcohol or benzodiazepines.

In its latest statement, the MCA said that up to January 10, 2002, a total of 6,975 reports of suspected adverse reactions had been received in Britain.

GlaxoSmithKline said in October that Zyban sales had slumped 34 per cent to 22 million pounds ($31 million) in the three months to September 30 following media coverage of reported deaths.

According to the MCA, Zyban is associated with a dose-related risk of seizure of approximately 0.1 per cent. It said 168 reports had been received in the UK of seizures suspected as being associated with the use of Zyban.

In half of the reports, patients had a history of seizures or seizure risk factors.

Last May, the UK Committee on Safety of Medicines issued a statement to doctors ordering changes to the starting dosages of Zyban and warning that patients at risk of a seizure should take the drug only if there were compelling reasons to do so.

It said at the time there had been over 5,000 adverse reports relating to Zyban, including 40 deaths.

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