Coroner calls for drug to be Withdrawn — (The Western Mail)

Original article no longer available

The Western Mail – The National Newspaper Of Wales

Madeleine Brindley

Mar 12 2003

THE world’s best-selling anti-depressant should be withdrawn from sale in the UK, a coroner said yesterday after linking the drug to the death of a retired Welsh teacher.

Geraint Williams added his voice to a growing body of health experts concerned about a link between Seroxat and suicide after hearing how Colin Whitfield killed himself just two weeks after starting a course of the drug.

Mr Williams will now call on the Department of Health to undertake an urgent inquiry into the controversial anti-depressant, which is manufactured by GlaxoSmithKline and prescribed to millions of people around the world.

Speaking at the inquest into the death of 56-year-old Mr Whitfield, the Brecon coroner said, “I have grave concerns that this is a dangerous drug that should be withdrawn until at least detailed national studies are undertaken.

“It is my intention to write to the Department of Health and the Secretary of State to ask him to hold an urgent inquiry into Seroxat and consider whether it should be withdrawn from sale in the UK.

“I am profoundly disturbed by the effect this drug had on Colin Whit-field,” he said. “It is quite clear that Seroxat has a profound effect on the thinking process of anyone who takes it.”

Mr Whitfield, who was described as a protective and loving father, died after cutting both his wrists on August 29 last year. He had locked himself in the garden shed at his home near Brecon while one of his daughters was asleep nearby. Just 14 days earlier, his GP had prescribed him Seroxat to treat anxiety.

His wife of 30 years, Kathryn, told the inquest, said, “I don’t believe this was a conscious decision, I don’t think it was an intentional act. There was no way he was in his right mind when he did that.

“There was no note and no intent. Two days before he died, on his birthday when he was opening presents, he asked, `What more can I ask for than my lovely family?’

“And on the night before he died he did and said three things that indicated he was planning ahead.”

She added, “It didn’t fit the picture of who he was and we have no doubt that it was the drug that caused him to do it.

“What he did was so totally out of character – he was a very caring, very protective father and husband. He would be hating himself for what he has done to his family.”

Seroxat was originally licensed as a treatment for depression but its use has now been expanded to cover obsessive compulsive disorder, panic disorder, anxiety and post-traumatic stress.

But while it has proved successful for many users, manufacturer GSK is facing the prospect of legal action from users and their families on both sides of the Atlantic amid claims the drug is addictive, and can prompt suicide and violent and aggressive behaviour.

Cardiff-based solicitors Hugh James, which is leading the action in the UK, is representing 4,000 people who claim they have been adversely affected.

The inquest heard that concern about the safety of the drug has increased since June 2001 when a jury in the US ordered GSK to pay $6.4m to the relatives of 60-year-old Donald Schell who killed his wife, his daughter and granddaughter before turning a gun on himself in 1998 in Wyoming. He had been taking Paxil – the American name for Seroxat – for just two days.

Since it was licensed for use in the UK in 1990, almost a quarter of all reports of fatalities from licensed medicines made to the Medicines Control Agency related to the use of Seroxat, said Mr Williams. And a third of all adverse incidents reported by doctors as part of the yellow card reporting scheme between 1991 and 1997 related to the use of the drug.

Clinical studies into Seroxat – a second generation selective serotonin re-uptake inhibitor (SSRI) – have found a higher risk of suicide or attempted suicide in patients on the drug compared to other SSRIs or a placebo, and healthy volunteers have dropped out of similar Seroxat studies because of the onset of suicidal thoughts and tendencies.

Research has also indicated that Seroxat, classed as a psychotropic drug, can cause “emotional blunt-ing” in some people, meaning they are more likely to act on thoughts they would normally dismiss.

In written evidence to the inquest, UK Seroxat expert Dr David Healy, director of the North Wales department of psychological medicine, said SSRIs caused a series of conditions which can increase the risk of suicide and it was common to find that people who are prescribed the drugs say they are “simply not bothered any more” and engage in “out of character behaviour”.

And his report said, “Based simply on the research done and the figures available, and without close consideration of Mr Whitfield’s case, there are good grounds to say an individual can commit suicide during the early time frame on an SSRI, but that individual is unlikely to have formed a consent to commit suicide in the normal fashion.”

In deciding to record an open verdict into Mr Whitfield’s death, Mr Williams said, “I have a picture of a kindly, gentle, courteous family man whose primary concern was his wife and children. But on this day he didn’t care.

“He did a deliberate act affected, I have no doubt, by the taking of Seroxat.”

In a statement from Glaxo -SmithKline, a spokeswoman last night said, “GSK offers its sincere condolences to the family of Colin Whitfield.

“As yet we do not have any official information from the court as the coroner is still sitting.

“We take the reporting of adverse events very seriously. The safety of all medicines is continually monitored by both GlaxoSmithKline and the Medicines Control Agency.

“Fortunately, with Seroxat we have a wealth of positive experience involving thousands of physicians, millions of patients and over 10 years of experience world-wide.

“There is no valid scientific research or literature finding that Seroxat causes suicidal thoughts or acts. Suicide can be a recognised component of depression.

“Fifteen per cent of all those suffering from depression eventually commit suicide. About 70% of the 4,000 suicides a year in Britain are people suffering from depression.

“We believe in the safety profile of Seroxat and will vigorously defend the integrity of our medication.”