Doctors Say Zyban May Be Linked to Deaths

BERLIN (Reuters) - German medical experts said on Tuesday that GlaxoSmithKline's smoking cessation drug Zyban may have played a role in five deaths in Germany, while the company said a link was unlikely.

``We have had four deaths of Zyban users in Germany. Two were suicides and the remaining two were heart attacks,'' Ulrich Hagemann, of Germany's Institute for Medicines, told Reuters.

``It is very difficult to distinguish between the basic disorder and the effects Zyban may have had, but we cannot exclude that Zyban may have aggravated the basic disorder,'' Hagemann said.

In a statement, GlaxoSmithKline said it was unlikely that Zyban, used worldwide by millions of smokers looking to kick the habit, had played a part in the deaths.

Professor Knut-Olaf Haustein from the Erfurt Institute for Nicotine Research said he had examined a fifth death of a Zyban user in Germany. ``The person suffered a heart attack a week after starting Zyban. Of course it may be that he would have suffered a heart attack anyway after giving up smoking, but it is not clear that Zyban was not the trigger for the death,'' Haustein said.

He said Zyban users were at risk from a wide range of side effects including depression.

A spokesperson for the British pharmaceutical giant, however, said that depression was often a side effect from giving up cigarettes, which contain nicotine, an anti-depressant.

``Every 50th smoker that gives up smoking suffers a major depression. In these matters it is very hard to distinguish between cause and effect,'' the spokesperson said.

Britain's drug regulatory body cited Zyban in June for a sharp rise in the number of suspected adverse drug events in the first 4 months of the year.

In 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.

Drug safety has come under the spotlight in Germany after it emerged in June that Bayer's blockbuster anti-cholesterol drug Baycol/Lipobay was linked to 52 deaths from muscle weakness. The company withdrew the product. GlaxoSmithKline co-marketed Baycol in the United States.

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