- GlaxoSmithKline, the world's second largest drug company,
conceded yesterday that the anti-smoking drug Zyban was suspected of causing
adverse reactions in 35 people who have died in the UK since it was introduced
last June.
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- The acknowledgement came at the inquest of Kerry Weston,
21, a British Airways air hostess who was found dead in a hotel room in
Nairobi, Kenya, in January, two weeks after she began taking the drug to
help her quit her 15-a-day habit.
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- Giving evidence on behalf of the pharmaceutical giant,
Dr Howard Marsh, senior medical adviser on Zyban to Glaxo, said that while
there had been 35 deaths following adverse reactions to Zyban, there was
no conclusive proof that any were directly linked to the drug.
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- "Although there has been this number of reports
of fatal events, it has to be said these are suspected adverse reactions,"
he told the inquest at Hertford coroner's court. "We are very keen
to look at each and every one of these cases very, very carefully to see
if there is a contribution from Zyban to any of these deaths. But the contribution
of Zyban to any of them remains unproven."
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- Zyban, which is taken in pill form, has been prescribed
to 360,000 patients in the UK. Of that number, 5,352 have reported adverse
reactions. Zyban is a "black triangle" drug, meaning it is new
to the market and has therefore to be monitored closely.
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- The Committee on the Safety of Medicines (CSM), which
monitors the introduction of new drugs and has scrutinised Zyban use, said
these figures where consistent with its expectations.
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- "Zyban is used in a population of patients who are
put at risk because of smoking and, therefore, reports of deaths of patients
receiving Zyban are to be expected," said Professor Alasdair Breckenridge,
CSM chairman.
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- "Where information is available, the majority of
patients who died had underlying conditions that provide an alternative
explanation. The CSM considers that the reports received are in line with
the known safety profile of Zyban, which is fully reflected in the product
information for health professionals and patients."
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- The inquest into Ms Weston's death heard that in addition
to Zyban she had taken non-prescription anti-malarial tablets and a sleeping
compound on the day she died. Dr Marsh told the court that in future Glaxo
would be warning that Zyban should not be taken in conjunction with anti-malarial
drugs.
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- He said people with a history of seizures, epilepsy,
manic depression or liver disease were already warned not to take the drug.
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- Ms Weston was prescribed the drug by the BA cabin crew
GP, Dr Mark Andrew.
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- "She described great difficulty with the problem
of smoking," Dr Andrews told the inquest.
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- "She requested help with this ... and what she called
the pill for smoking."
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- Aware that the drug was under scrutiny, Dr Andrews prescribed
a fortnight's supply and told Ms Weston to return when she had taken the
pills.
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- Her mother, Eileen Weston, told the court that shortly
after her daughter began taking Zyban she passed out at Gatwick airport
after returning from Baltimore.
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- "She remembered feeling unwell and then all she
remembered was waking up on the bathroom floor as if she had gone to sleep,"
Mrs Weston said. "Her words were that she thought she had fallen asleep
in the bathroom but her head was very sore when she stood up."
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- Shortly afterwards, Ms Weston flew to Nairobi. Colleagues
on the plane said she seemed well, but became concerned when she failed
to turn up for a drink in the cabin crew's hotel.
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- Steward Philip Stuart said hotel staff had to force open
the door to her room. He said: "We could see Kerry inside lying on
the floor with her head close to the door. "We put our hand in and
felt her neck. She was still warm and clammy."
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- When the group entered the room they discovered Kerry
had vomited and that her nose and legs were turning blue.
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- Zyban or bupropin hydrochloride, developed as an anti-depressant,
was found to ease the desire for nicotine, even in heavy smokers. It works
by supressing the neurotransmitters dopamine and noradrenaline - the brain's
"pleasure centres" - which are stimulated by nicotine. Glaxo
sank millions into marketing it. More than 1m Americans claim to have stopped
smoking after taking the drug.
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