Fwd: [SSRI-Research] Damning verdict expected today on GSK's Seroxat (Paxil)

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Tue, 10 Jun 2003 11:30:38 -0000

[sSRI-Research] Damning verdict expected today on GSK's Seroxat (Paxil)

 

Tue 10 Jun 2003

GSK faces fresh Seroxat (Paxil) woe

 

WILLIAM LYONS

http://www.thescotsman.co.uk/business.cfm?id=d0102003

 

A GOVERNMENT agency is today expected to deliver a damning

verdict on GlaxoSmithKline's widely-criticised anti-depressant

Seroxat.

 

The Medicines and Healthcare Products Regulatory Agency

(MHRA) will outline new advice for patients and prescribers

about Seroxat, which contributes more than £2 billion of annual

turnover to GSK.

 

The new guidelines will focus on potential side-effect problems

among under-18s, according to sources.

 

Industry speculation has been mounting of the MHRA raiding

GSK's laboratories and offices to investigate allegations that the

drugs giant has suppressed a series of negative studies

surrounding Seroxat - known as Paxil in the US.

 

The drug has been linked to suicidal behaviour, with public

concerns also growing over potential withdrawal reactions.

Yesterday a GSK spokesman refused to comment on whether a

clinical audit will be carried out but confirmed that it is in talks

with the MHRA.

 

" We have been in discussions with the regulatory authorities

regarding updates to Seroxat labelling. However, it's not

appropriate to discuss further until we have seen the outcome, "

he said.

 

The investigation comes as more bad news for GSK, which has

been rocked by a string of delays to new drugs, including the

asthma treatment Advair. It also courted controversy last month

when it became the first blue-chip company to see its

remuneration package thrown out by shareholders.

 

GSK's shares have recovered to 1,249p this year after falling

below £10 in 2002, but the MHRA's findings might threaten that,

as sales in Seroxat, which sees its patent expire in 2006,

reached £375 million in Europe last year.

 

A previous attempt to investigate the safety profile of

anti-depressants was abandoned in March after two of the group

members were linked to drug companies. But two weeks ago -

following an exposé on the BBC's Panaroma programme - an

expert group, chaired by Ian Weller, Professor of Genitourinary

Medicine at London's Royal Free hospital, was set up to review

the drug.

 

Earlier this year, Brecon coroner Geraint Williams said the drug

should be withdrawn while its safety was fully investigated, after

recording an open verdict on Colin Whitfield, who killed himself a

short time after starting to take the drug.

 

It is believed GSK will be asked by the MHRA to contact general

practitioners, letting them know of the potential dangers to

people under 18. Although the drug is not officially approved for

use among under-18s in Britain, doctors have the discretion to

prescribe on an " off-label " basis.

 

Two years ago, a jury in the US awarded US$6.4m (£3.9m) to the

family of a man who murdered his wife, daughter and

grand-daughter and then committed suicide in what the family

claimed was a reaction to the drug. GSK denies the connection.

 

 

 

 

 

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