Seroxat / Hugh James blast from the past - Mark Harvey said "We hope to avoid litigation" Dec 2002.

Review on 'side effects' of drug
From the Northern Echo, first published Monday 30th Dec 2002.

AN intensive review is being carried out by the Government's medical watchdog into the controversial anti-depressant drug Seroxat.

Thousands of users of the drug, including scores in the North-East and North Yorkshire, have reported serious adverse effects while trying to come off the drug, which is manufactured by pharmaceuticals company GlaxoSmithKline.

Seroxat, one of a class like Prozac which is known as selective serotonin re-uptake inhibitors (SSRIs), is prescribed for mild depression, anxiety's and phobias.

But users have reported terrible head pains - described as being like electric shocks - mood swings and suicidal tendencies as they have tried to stop taking the drug, with the process taking years for many people.

One Durham man, who does not want to be named, has already spent a year gradually withdrawing from Seroxat, and said he had tried going "cold turkey" - stopping entire usage - only for him to turn into "a wild animal".

"It was so frightening," said the 32-year-old, who initially went on Seroxat as a short-term solution to combat work-related stress.

"Your whole personality seems to change. I'm still reducing the dosage and I can foresee it will take another two to three months.

"I just want to get off this thing so I can get my life sorted out."

Since the publicity surrounding Seroxat, a working party with the Department of Health's executive body, the Medicines Control Agency (MCA), is looking at all SSRIs, and in particular withdrawals from Seroxat.

More than 4,000 users, who want to see tougher warnings about the drug's effects and research carried out into dependency problems, are considering taking joint legal action through Cardiff-based solicitors, Hugh James.

Mark Harvey, a partner with the firm, said: "We hope to avoid litigation, but I think that is the way it's going to go unless there's significant changes.

"It seems to me that the ground is shifting if the Government now accepts that there clearly is a significant problem here."

Campaigners also want the "Yellow Card" scheme - whereby doctors report medicines' side effects - to include reports direct from patients.

Between 70 and 80 MPs signed an Early Day Motion in November into the effects of the drug.

Glaxo has always maintained that the drug is safe and there is no evidence that it leads to addiction.

A spokeswoman for the company said: "GlaxoSmith-Kline works with the regulatory authorities on an ongoing basis to evaluate the safety and efficacy of all our medicines based on the most recent data, and this (MCA) review is part of that continuous dialogue.

A spokesman for the Department of Health said: "At the moment, there is no new safety issue. If the MCA comes to any conclusions, they will put their recommendations to the Committee on Safety of Medicines, who will advise the MCA on what action to take."


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