March 13

Coroner calls for withdrawal of Seroxat (PAXIL)

Coroner calls for withdrawal of Seroxat (PAXIL)

March 13, 2002

Following the death of a 56 year old retired headmaster within two weeks of taking the antidepressant, Seroxat (PAXIL), a British coroner told a court “”I have grave concerns that this is a dangerous drug that should be withdrawn until at least detailed national studies are undertaken.”

PAXIL and the other SSRI antidepressants are shrouded in controversy as they have been implicated in the deaths of previously non-suicidal persons who have suddenly and without warning taken their lives. The UK medicines control agency announced a review of Seroxat “after growing concern about withdrawal symptoms and side effects.”

Dr. David Healy, a leading psychopharmacologist who has examined the clinical trial data of SSRI drugs, in his capacity as an expert witness, has undertaken a campaign to bring about drug label changes that would disclose the risks of these antidperessant drugs to physicians and the public, and to educate coroners across the UK about the drugs hazardous effect on a minority of patients.,8150,913400,00.html
The Guardian

Coroner calls for inquiry into Seroxat

Sarah Boseley, health editor Thursday March 13, 2003

Seroxat, the world’s biggest-selling antidepressant, should be withdrawn while its safety is fully investigated, advises a coroner who recorded an open verdict on a man who killed himself within a fortnight of starting a course of the drug.

The Brecon coroner, Geraint Williams, said he would be writing to the Department of Health about his finding that Seroxat led to Colin Whitfield, 56, a retired headteacher, taking his own life.

“I have grave concerns that this is a dangerous drug that should be withdrawn until at least detailed national studies are undertaken,” he told the court on Tuesday.

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and to the secretary of state to ask him to hold an urgent inquiry into Seroxat and consider whether it should be withdrawn from sale in the UK.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

Evidence indicated that Mr Whitfield suffered a change of personality after starting to take the drug.

Seroxat, whose generic name is paroxetine, is in the class of drugs, with Prozac, termed SSRI or selective serotonin reuptake inhibitors. It has overtaken Prozac in sales. Both drugs are prescribed mainly by GPs. There have been several strongly contested legal cases in the US against makers of SSRIs after suicides among those taking the drugs over a couple of weeks, or even days.

Almost two years ago, the former SmithKline Beecham (now GlaxoSmithKline) was ordered by a Wyoming jury to pay £4.7m to the family of Donald Schell, who killed his wife, daughter, baby grand daughter and then himself after two days on Seroxat – known as Paxil in the US.

In that case, evidence was given by a British psychopharmacologist, David Healy, the director of the North Wales department of psychological medicine, who was granted access to GlaxoSmithKline’s archives. He found that a small number of volunteers in perfect health, who took part in early trials of the drug, had become very agitated or suicidal.

Dr Healy has given evidence to a number of coroners’ inquests in the UK, including that over Mr Whitfield’s death.

“A lot of people going into the inquest just know the person would not have committed suicide in the normal course of events. You get a sense of their utter bewilderment,” he said.

Most coroners did not know about the controversy. Dr Healy wrote to 148 coroners in England and Wales, and also to the review of coroner services, which was set up after the Harold Shipman case.

Dr Healy advises that statistics on deaths of people on SSRIs be centrally collected.

He has also pointed out that suicide verdicts – which could be wrong in cases concerning the antidepressant – deprive relatives of insurance payouts.

GlaxoSmithKline insists the drug is safe, saying its experience with Seroxat involves “thousands of physicians, millions of patients and over 10 years of experience world-wide”. It states that there is “no valid scientific research finding that Seroxat causes suicidal thoughts or acts”.

Last year, the medicines control agency announced a review of Seroxat after growing concern about withdrawal symptoms and side effects.

Colin Whitfield, 56, was a retired headmaster. His wife Kathryn told Brecon coroner’s court that he had never shown any inclination towards suicide.

He was prescribed Seroxat for anxiety, not depression. If his GP had thought he might be a suicide risk, it is likely he would have referred him to a hospital psychiatrist.

She said he was a loving father who would never have wanted to distress his family. Yet last autumn he locked himself in the garden shed and cut both wrists, while one of his daughters was sleeping not far away.

“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,” she said.

“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.”

The suicide “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. He was a very caring, very protective father and husband. He would be hating himself for what he has done to his family.”

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