GSK faces fresh Seroxat woe
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.
guidelines will focus on potential side-effect problems among
under-18s, according to sources.
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
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
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coroner Geraint Williams said the drug should be withdrawn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.
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