The Scotsman - Business - 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.

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Earlier this year, Brecon coroner Geraint Williams said the drug should be withdrawn while its safety was fully investigated, after recording an open verdict on Colin Whitfield, who killed himself a short time after starting to take the drug.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.