Antidepressants
can raise the risk of suicide, the biggest ever review has found, as
pharmaceutical companies were accused of failing to report side-effects
and even deaths linked to the drugs.
An analysis of 70 trials of the most common antidepressants - involving more than 18,000 people - found they doubled the risk of suicide and aggressive behaviour in under 18s.
An analysis of 70 trials of the most common antidepressants - involving more than 18,000 people - found they doubled the risk of suicide and aggressive behaviour in under 18s.
Although a similarly stark link
was not seen in adults, the authors said misreporting of trial data
could have led to a ‘serious under-estimation of the harms.’
For years families have claimed that antidepressant medication drove
their loved ones to commit suicide, but have been continually dismissed
by medical companies and doctors who claimed a link was unproven.
The review - the biggest oif its kind into the effects of the drugs - was carried out by the Nordic Cochrane Centre and analysed by University College London (UCL) who today endorse the findings in an editorial in the British Medical Journal (BMJ).
After comparing clinical trial information to actual patient reports the scientists found pharmaceutical companies had regularly misclassified deaths and suicidal events in people taking anti-depressants to "favour their products".
Experts said the review's findings were "startling" and said it was "deeply worrying" that clinical trials appear to have been misreported.
The review - the biggest oif its kind into the effects of the drugs - was carried out by the Nordic Cochrane Centre and analysed by University College London (UCL) who today endorse the findings in an editorial in the British Medical Journal (BMJ).
After comparing clinical trial information to actual patient reports the scientists found pharmaceutical companies had regularly misclassified deaths and suicidal events in people taking anti-depressants to "favour their products".
Experts said the review's findings were "startling" and said it was "deeply worrying" that clinical trials appear to have been misreported.
Drugs like citalopram can cause serious withdrawal symptoms
Dr Joanna
Moncrieff from University College London said: "People in the United
Kingdom are consuming more than four times as many antidepressants as
they did two decades ago. Despite this, we still do not fully understand
the effects of these drugs.”
The UK now has the seventh highest prescribing rate for antidepressants in the Western world, with around four million Britons taking them each year - twice as many as a decade ago at a cost of more than £200 million a year for the 53 million prescriptions now written.
The UK now has the seventh highest prescribing rate for antidepressants in the Western world, with around four million Britons taking them each year - twice as many as a decade ago at a cost of more than £200 million a year for the 53 million prescriptions now written.
Although NHS guidelines state that under 18s should not be given antidepressants there
are more than 100,000 prescriptions for Prozac each year for teenagers,
despite reviews showing that the drugs are no more effective than
counselling.
The review looked at the five most common drugs prescribed for depression in Britain - including Prozac.
It analysed the published summary reports provided by pharmaceutical companies to drugs regulators and compared it with the raw data from clinical trials.
Tarang Sharma of the Nordic Cochrane Centre, Copenhagen, Denmark admitted: “The analysis suggests that clinical study reports, on which decisions about market authorisation are based, are likely to underestimate the extent of drug related harms.”
Four deaths were misreported by one unnamed pharmaceutical company, who claimed they had occurred after the trials had stopped.
One patient strangled himself unexpectedly after taking venlafaxine but because he survived for five days, he was excluded from the results because it was claimed he was no longer on the trial while he was dying in hospital.
The review looked at the five most common drugs prescribed for depression in Britain - including Prozac.
It analysed the published summary reports provided by pharmaceutical companies to drugs regulators and compared it with the raw data from clinical trials.
Tarang Sharma of the Nordic Cochrane Centre, Copenhagen, Denmark admitted: “The analysis suggests that clinical study reports, on which decisions about market authorisation are based, are likely to underestimate the extent of drug related harms.”
Four deaths were misreported by one unnamed pharmaceutical company, who claimed they had occurred after the trials had stopped.
One patient strangled himself unexpectedly after taking venlafaxine but because he survived for five days, he was excluded from the results because it was claimed he was no longer on the trial while he was dying in hospital.
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More than
half of the suicide attempts and suicidal thoughts had been misrecorded
as emotional instability or worsening of depression. In summary trial
reports from the drugs giant Eli Lilly, suicidal attempts were missing in 90 per cent of cases.
One father whose son committed suicide after taking Citalopram has been monitoring suicides related to antidepressant medication for the last three years and has set up the anonymous campaigning website AntiDepAware.
So far this month there have been at least 35 inquests with deaths linked to antidepressants. Last year there were more than 450.
One father whose son committed suicide after taking Citalopram has been monitoring suicides related to antidepressant medication for the last three years and has set up the anonymous campaigning website AntiDepAware.
So far this month there have been at least 35 inquests with deaths linked to antidepressants. Last year there were more than 450.
“I can say, hand on heart, that I don’t remember reading a report of
an inquest where a suicide verdict was applied to a child who had never
been on any psychiatric medication,” he said.
Professor Peter Gøtzsche, the lead author from the Nordic Cochrane Centre said: "Antidepressants don't work in children, that is pretty clear, in the randomised trials children say that they don't work for them, but they increase their risk of suicide.
"What I get out of this colossal underreporting of suicides is that SSRIs likely increase suicides in all ages."
Professor Peter Gøtzsche, the lead author from the Nordic Cochrane Centre said: "Antidepressants don't work in children, that is pretty clear, in the randomised trials children say that they don't work for them, but they increase their risk of suicide.
"What I get out of this colossal underreporting of suicides is that SSRIs likely increase suicides in all ages."
The
authors concluded that that exercise and psychotherapy should be offered
to children and young adults before anti-depressants because that harms
are likely to outweigh the benefits.
The drugs which reviewed were duloxetine, fluoxetine - which is also known as Prozac - paroxetine, sertraline and venlafaxine which belong to two classes, Selective serotonin reuptake inhibitors antidepressants (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).
Commenting on the findings of the review Professor Gotzsche added, "It is absolutely horrendous that they have such disregard for human lives."
The drugs which reviewed were duloxetine, fluoxetine - which is also known as Prozac - paroxetine, sertraline and venlafaxine which belong to two classes, Selective serotonin reuptake inhibitors antidepressants (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).
Commenting on the findings of the review Professor Gotzsche added, "It is absolutely horrendous that they have such disregard for human lives."
Lucie Russell, Director of Campaigns for YoungMinds:
“This new study is deeply worrying, and it’s very concerning that some
clinical trials have been misreported or poorly designed.
“Children and their parents must have solid and comprehensive information about the effects that antidepressants can have so they can make informed decisions about treatment.
“We believe that prescribing antidepressants should never be the only course of action.”
Marjorie Wallace, Chief Executive of the mental health charity SANE added: “This new report indicates that great caution must be taken in prescribing new-generation anti-depressants (SSRIs) for children and adolescents."
“Children and their parents must have solid and comprehensive information about the effects that antidepressants can have so they can make informed decisions about treatment.
“We believe that prescribing antidepressants should never be the only course of action.”
Marjorie Wallace, Chief Executive of the mental health charity SANE added: “This new report indicates that great caution must be taken in prescribing new-generation anti-depressants (SSRIs) for children and adolescents."
Health experts said misreporting of trial data was a growing problem.
Dr Paul Ramchandani, Consultant Child and Adolescent Psychiatrist with Central North West London Foundation NHS Trust said: “There have been concerns for a number of years about the way in which some trials of medicines or drugs for depression were originally reported, particularly when the treatment was for children and adolescents.”
Dr Paul Keedwell, Consultant Psychiatrist and Senior Research Fellow in the Neurobiology of Mood Disorders at Cardiff University, added:“The findings provide a further lesson in how professionals must carefully scrutinise drug company summaries for data on adverse events.”
However drug companies defended their data, saying that safety was their top priority.
A spokesman for Eli Lilly said: “No regulatory authority has ever determined that Lilly withheld or improperly disclosed any data related to these medications.
“Put simply, our goal is to make life better for people around the world, and Lilly is committed to sharing the results of our clinical trials and ensuring this information is available to the people who need it.”
CASE STUDY
Dr Margaret Tisdale, 64, was a renowned virologist who helped develop treatments for HIV, AIDS and influenza.
Dr Paul Ramchandani, Consultant Child and Adolescent Psychiatrist with Central North West London Foundation NHS Trust said: “There have been concerns for a number of years about the way in which some trials of medicines or drugs for depression were originally reported, particularly when the treatment was for children and adolescents.”
Dr Paul Keedwell, Consultant Psychiatrist and Senior Research Fellow in the Neurobiology of Mood Disorders at Cardiff University, added:“The findings provide a further lesson in how professionals must carefully scrutinise drug company summaries for data on adverse events.”
However drug companies defended their data, saying that safety was their top priority.
A spokesman for Eli Lilly said: “No regulatory authority has ever determined that Lilly withheld or improperly disclosed any data related to these medications.
“Put simply, our goal is to make life better for people around the world, and Lilly is committed to sharing the results of our clinical trials and ensuring this information is available to the people who need it.”
CASE STUDY
Dr Margaret Tisdale, 64, was a renowned virologist who helped develop treatments for HIV, AIDS and influenza.
The
church warden was a well-known pillar of the community in her village of
Wrestlingworth in Bedfordshire, and a chair of school governors at the
local primary.
But on April 29 last year she was found unconscious in her garden having fallen from the window. On her bedside table was a copy of a self-help book on coping with stress and her antidepressant tablets.
An inquest last October heard how in the months leading to her death she had stressed about the amount of voluntary work she had taken on and a doctor prescribed Citalopram.
A coroner ruled that she had committed suicide after being ‘overtaken by stress.’
However at the hearing, her sister Linda Foreman raised concerns about the side effects of her medication.
She said: “I felt that she wasn’t depressed, but was instead very anxious and stressed. I was concerned about the Citalopram she was prescribed, when I looked up the side effects. I don’t think she knew how serious the side effects could be.”
Speaking after the hearing she added: “Margaret was not depressed but suffering from stress and anxiety.
“I now know that antidepressants are prescribed too frequently and far better results would be achieved through counselling.”
But on April 29 last year she was found unconscious in her garden having fallen from the window. On her bedside table was a copy of a self-help book on coping with stress and her antidepressant tablets.
An inquest last October heard how in the months leading to her death she had stressed about the amount of voluntary work she had taken on and a doctor prescribed Citalopram.
A coroner ruled that she had committed suicide after being ‘overtaken by stress.’
However at the hearing, her sister Linda Foreman raised concerns about the side effects of her medication.
She said: “I felt that she wasn’t depressed, but was instead very anxious and stressed. I was concerned about the Citalopram she was prescribed, when I looked up the side effects. I don’t think she knew how serious the side effects could be.”
Speaking after the hearing she added: “Margaret was not depressed but suffering from stress and anxiety.
“I now know that antidepressants are prescribed too frequently and far better results would be achieved through counselling.”
