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Wednesday, 23 June 2010

Seroxat - Coroner says difficult to link Paxil to death - Sara Carlin inquest

Coroner says difficult to link Paxil to death



http://www.insidehalton.com/news/article/837321--coroner-says-difficult-to-link-paxil-to-death




"The fact that an individual commits suicide while taking an anti-depressant does not mean that anti-depressant had a role in the suicide."- Dr. Bert Lauwers,coroner presiding over Sara Carlin inquest. The coroner presiding over the inquest into the death of Sara Carlin, 18, advised the jury Tuesday that the anti-depressant Paxil does not appear to have been a factor in her death.

Sara, an Oakville resident and graduate of St. Ignatius of Loyola Catholic Secondary School, hanged herself in her parents’ basement on Sunday, May 6, 2007.

At the time of her death, Sara had been taking Paxil, a selective serotonin reuptake inhibitor (SSRI) medication, for more than a year despite Health Canada advisories warning doctors in 2003 and 2004 that Paxil was not recommended for people under 18 due to the increased risk of suicidal events.

A Coroner's inquest into Sara's death has lasted for more than two weeks as more than 30 witnesses were called to determine the circumstances surrounding Sara's death, how much of a role Paxil may have played and if anything can be done to prevent similar deaths in the future.

During these two weeks of testimony, the jury heard from a number Sara's family and friends, who stated she went through radical emotional and behavioural changes after she began taking Paxil in February of 2006.

The jury heard from witnesses that three of the side effects of Paxil, listed on the product monograph, are depression, increased alcohol consumption and drug dependence.

They also heard from Dr. Mary Alexander, a psychotherapist who saw Sara once, that Sara said she had experienced depression and had been drinking heavily for more than a year before she began taking Paxil.

To make sense of all this, the presiding coroner, Dr. Bert Lauwers, advised the jury to consider the testimony of Dr. David Juurlink, head of the division of pharmacology and toxicology at Toronto's Sunnybrook Hospital and medical toxicologist at the Ontario Regional Poison Information Centre in Toronto's Hospital for Sick Children.

Juurlink testified that making a determination that an anti-depressant like Paxil was responsible for a person's suicide is difficult because the reason the person is taking the anti-depressant is normally due to depression, which can lead to suicide.

"The fact that an individual commits suicide while taking an anti-depressant does not mean that anti-depressant had a role in the suicide," said Lauwers.

In his testimony, Juurlink said Paxil can cause people to commit suicide, but added he did not believe this to have happened in Sara Carlin's case.

Lauwers repeated Juurlink's reasoning that most suicides and side effects occur within the first few weeks and months after a person starts taking Paxil. Sara had been taking the drug for more than a year before her death.

Juurlink testified Sara had reported responding favourably to treatment. He said there were competing reasons for her suicide including psychosocial factors and alcohol and cocaine use.

"He addressed the issue of the SSRI (Selective serotonin reuptake inhibitor) Discontinuation Syndrome," said Lauwers. "He stated and I quote, 'There is no evidence in the record that Ms. Carlin displayed the characteristic features of SSRI discontinuation in the days leading up to her death. Moreover, if there was an interruption of therapy followed by a reintroduction of the drug at higher than prescribed doses this does not alter my opinion. Paroxetine was not a causal factor in her suicide."

The Carlins’ lawyer Gary Will has pointed out that Sara was experiencing flu-like symptoms during the one to four-day period she was without her Paxil just before her death in May of 2007.

Lauwers also drew the jury's attention to Dr. Paul Links' testimony.

Links, a professor of psychiatry at the University of Toronto and past president of the Canadian Association for Suicide Prevention also said alcohol and cocaine use were the more likely the cause of Sara's death.

"The acute use of alcohol and cocaine can contribute to the risk of suicide in several ways. Alcohol intoxication and cocaine withdrawal can precipitate an acute disphoric state, increase psychological distress and trigger acute suicidality," said Lauwer, reading Links' comments. "During intoxication the individual may be more disinhibited."

Lauwers went on to point out that Links had concluded there was not much evidence to say Paxil had contributed to Sara's death.

During cross-examination by Will, Links did admit the explanation that Paxil played a role in Sara's death was plausible, but not an explanation he would favour.

Lauwers told the jury he was surprised during the inquest by the prevalence of underage drinking taking place in Oakville as evidenced by several witnesses.

The prevalence of cocaine among youths in Oakville was something else he found concerning.

The degree of suicidal thinking and behaviour among youths, which emerged during Links' testimony, was something else that caught Lauwers' attention. Links pointed out that according to a 2001 survey, 19 per cent of high school students have thought about suicide, 15 per cent have developed a suicide plan while nine per cent have actually made a suicide attempt.

To deal with these issues, Lauwers has suggested the jury recommend that the Halton Regional Health Department develop an education program regarding mental health and substance abuse for adolescents in its school system.

This program should seek to inform adolescents and youths in Halton schools that suffering from mental health disorders including depression and anxiety is common at their age.

This program would seek to de-stigmatize mental illness, provide information that these conditions are treatable. He suggested the program emphasize abstinence from alcohol and other substances that may bring about suicidal thinking and even suicide.

Lauwers said the jury could also recommend the Ministry of Education and the Ministry of Health and Long-Term Care create a similar program on a provincial scale for all Ontario schools.

While the coroner listed a great deal of information indicating Paxil was not responsible for Sara's death, this did not stop him from suggesting the jury make recommendations for greater drug safety in Canada.

These suggestions included the creation of a province-wide Drug Information System that would track and monitor all drugs dispensed in Ontario.

It was pointed out such a system could aid researchers greatly in their research into drug-related adverse events.

Another suggestion called for the creation of a province-wide Suicide Prevention Strategy that would seek to enhance mental health and well-being of Ontarians, de-stigmatize mental health disorders, improve intervention and support for Ontarians affected by depression and substance abuse, improve intervention in the treatment of those who are at risk of suicide, increase research activities in Ontario with regard to suicide, suicidal behaviour and suicide prevention, inform and educate the media about strategies when reporting deaths due to suicide to prevent 'copy cat' suicides from occurring.

Other suggestions called for the Canadian Medical Protective Association to encourage physicians to involve the families of children, adolescents and young adults when they are being treated with medications for mental disorders like anxiety and depression whenever possible.

This will allow the patient and the family to be aware of the nature of the patients' disorder and the potential side effects of the medication they are taking.

Some of the other recommendations put forward by the coroner dealt with doctors being required to report serious adverse drug events to Health Canada; weekly appointments during a patient's first month of taking an SSRI; stricter emphasis that prior to a youth being put on an SSRI they go through a thorough diagnostic consideration and evaluation, a physical examination, laboratory investigations where appropriate, a discussion with the patient's family (if possible) with respect to target symptoms and monitoring, and an inquiry and consideration of alcohol and substance abuse being confounders of the illness.

The jury is now in deliberations and will consider these along with 26 other recommendations made by the Carlin family with respect to preventing deaths similar to Sara's in the future.

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