EU Agency to Review Zyban Smoking
02/22/02 - The
European Medicines Evaluation Agency said on
Friday 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.
German concerns follow five reported deaths in
patients taking Zyban since it was launched in
A spokesman for the agency in London
said the review was expected to last several
On January 17, 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.
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
"You have to remember that
Zyban plays a major role in helping smokers to
stop and therefore reduces the burden and
mortality of smoking.
"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 issued a reminder last month that the
drug should not be prescribed to patients with a
history of seizures, bulimia or anorexia nervosa,
or those experiencing abrupt withdrawal from
alcohol or benzodiazepines.