From: Subject: News Date: Mon, 21 Jun 2004 19:30:50 +0200 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_016B_01C457C6.42A27260"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1409 This is a multi-part message in MIME format. ------=_NextPart_000_016B_01C457C6.42A27260 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://news.independent.co.uk/business/news/story.jsp?story=533229 News

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GSK facing UK lawsuit over anti-depressant

By Tim Webb

20 June 2004

Lawyers in the UK are preparing a multi-million-pound class = action suit=20 against drugs giant GlaxoSmithKline over its anti-depressant drug=20 Seroxat.

To be launched next month, the action will come as another blow = to GSK=20 after New York attorney general Eliot Spitzer filed a lawsuit = against the=20 company over its US version of the drug, called Paxil. Analysts = said that=20 worries about mounting litigation over Paxil/Seroxat would hit = shareholder=20 sentiment.

The UK Seroxat Users' Group, a voluntary organisation made up = of 3,500=20 members, alleges that the drug is a "defective product" under the = Consumer=20 Protection Act. It says that the drug causes users to have = suicidal=20 tendencies and withdrawal symptoms, and to display aggressive = behaviour -=20 far worse than those associated with other anti-depressants.

Lawyers acting for the group are expected to write to GSK next = month to=20 give it formal notice of the action. If GSK contests the = allegations, the=20 case will go to court. It could take several years to come to = trial, which=20 will create further uncertainty for the company.

Mark Harvey, a partner at law firm Hugh James, which is leading = the=20 action, said: "The Spitzer case was a psychological boost. The = case=20 reflects what we have been saying."

The claimants are seeking unspecified compensation for their = use of the=20 drug and to provide funding to allow them to come off Seroxat = safely. It=20 also wants GSK to provide more information about how to stop = taking the=20 drug.

Seroxat was launched in the UK in 1991 to treat depression and = anxiety.=20 But concerns have grown about its side effects. Last year, the UK=20 medicines regulator, the MHRA, banned doctors from prescribing = Seroxat to=20 under-18s.

Following complaints from patients, GSK agreed last

summer to remove from the patient information leaflet an = assertion that=20 the drug is not addictive.

The company also advised users that there is a withdrawal = reaction in=20 25 per cent of patients, compared with earlier advice that 7 per = cent of=20 users showed this reaction.

A spokesman for GSK said: "Over time, patient information = leaflets and=20 prescribing information for GPs change. It's normal as companies = learn=20 more."

He pointed out that in clinical trials for the drug, 15 per = cent of=20 users who were unknowingly given a placebo, rather than Seroxat = itself,=20 displayed withdrawal symptoms. He said that GSK still believes = that=20 Seroxat is not addictive, and only removed the reference to be = more=20 helpful to users.

"There is ongoing monitoring of Seroxat," he added. "It's = important=20 patients have the right information to help them take the drug in = the=20 right way."

Elaine Lowman, 48, from Kent, is one of the 3,500 members of = the=20 Seroxat Users Group taking part in the action. "I have lost a year = of my=20 life," she said. "I became more aggressive, I started getting the = sweats.=20 My GP said the drugs were not addictive. The leaflet did not say = anything=20 about coming off the dose gradually. But when I stopped taking it = I had=20 withdrawal symptoms within a day."

=20

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