EMEA to review Glaxo's Zyban smoking cessation drug

מתוך medicontext.co.il
By Richard Woodman

LONDON (Reuters Health) – The European Medicines Evaluation Agency said on Friday that it is reviewing GlaxoSmithKline's smoking cessation drug Zyban following safety concerns.

In a statement, it said its scientific committee would examine the risks and benefits of the drug at the request of Germany.

The German concerns follow five reported deaths in patients taking Zyban since it was launched in 2000. A spokesman for the agency in London said the review was expected to last several months.

Shares in GSK fell 3.5% on January 17 when Britain's Medicines Control Agency reported that it had received 6,975 reports of suspected adverse drug reactions, including 57 deaths.

However British drug regulators have stressed that the drug's contribution to the deaths is "unproven" and that in most cases the individual's underlying condition might have been responsible.

The number of reported side effects remains small compared to the risks of smoking and relative to the large number of prescriptions issued. An estimated 500,000 people have taken Zyban in Britain and more than 330,000 in Germany.

A GSK spokesman said that the firm welcomed the review as a chance to support the drug and would respond to all requests for information.

"You have to remember that Zyban plays a major role in helping smokers to stop and therefore reduces the burden and mortality of smoking," he said. "In the UK alone 120,000 deaths a year are due to smoking-related illnesses–more than 300 a day."

Regulators suspect that many of the reported side effects have occurred in patients who should not have been prescribed the drug.

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.

The UK Medicines Control Agency also reminded doctors last month that 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.

Zyban had sales of £129 million last year, half in the United States. The drug was first launched as an anti-depressant under the brand name Wellbutrin, which had sales of £647 million in 2001.

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