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GlaxoSmithKline Admits Zyban
Linked To 35 UK Deaths
Since Last June
By Paul Kelso
The Guardian http://www.guardianunlimited.co.uk
4-27-1

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.
 
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.
 
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.
 
"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."
 
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.
 
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.
 
"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.
 
"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."
 
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.
 
He said people with a history of seizures, epilepsy, manic depression or liver disease were already warned not to take the drug.
 
Ms Weston was prescribed the drug by the BA cabin crew GP, Dr Mark Andrew.
 
"She described great difficulty with the problem of smoking," Dr Andrews told the inquest.
 
"She requested help with this ... and what she called the pill for smoking."
 
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.
 
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.
 
"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."
 
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.
 
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."
 
When the group entered the room they discovered Kerry had vomited and that her nose and legs were turning blue.
 
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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