quick to remind doctors that it believes SSRI antidepressants are
UK drug regulator was quick to remind doctors last week that its
research finds that, on balance, SSRI antidepressants are safe.
reminder was published on the website of the Medicines and Healthcare
products Regulatory Agency (MHRA).
followed the publication on Friday of research finding that patients
are twice as likely to exhibit suicidal behaviour when on SSRIs,
compared to those on placebos and other forms of treatment.
(the online version of the British Medical Journal) published a
paper by Dean Fergusson of the Ottawa Health Research Institute
in Canada and colleagues which had reviewed 702 randomised controlled
trials including 87,650 participants.
found significantly higher probabilities of suicide attempts for
patients on SSRIs than placebos.
meta-analysis did not detect a difference between SSRIs and tricyclic
said that a number of major methodological limitations of the published
trials may have led to underestimates of the risk of suicide attempts.
second study published by Bmj.com was carried out by the department
of epidemiology of Bristol University.
looked at data from 477 published and unpublished trials submitted
to the MHRA by the pharmaceutical companies for the recent MHRA
review of the safety of the SSRIs.
found that because of the small numbers of people in the trials
who actually killed themselves, it was not possible to rule out
either a threefold increase or decrease in suicide on the drugs.
third study compared people put on SSRIs by their GP for the first
time with those given the tricyclics.
found no difference in the number of suicides and episodes of self-harm.
to the research, the MHRA's website reminded doctors and other healthcare
professionals of its December advice from a expert working group
that, overall, the benefits of SSRIs for adults outweigh risks.
The advice adds that frequent monitoring of patients is important.
Ian Weller, chair of the expert working group, said: "The group
conducted the largest review ever of evidence relating to SSRIs.
considered a huge range of evidence, both published and unpublished,
including the studies published in the British Medical Journal.
these studies therefore make an important contribution to the published
literature on this subject, they have already been considered by
the group along with all the other evidence, and they do not alter
Weller continued, "SSRIs are an important group of medicines
which have made a vital contribution to improving the lives of many
patients who are living with moderate to severe depression. The
balance of risks and benefits remains positive in those groups of
patients for whom this medicine is licensed."
The MHRA's December 2004
advice on SSRIs for healthcare professionals
paper : Selective serotonin reuptake inhibitors (SSRIs) and suicide
in adults: meta-analysis of drug company data from placebo controlled,
randomised controlled trials submitted to the MHRA's safety review
paper: Antidepressant treatment and the risk of fatal and non-fatal
self harm in first episode depression: nested case-control study
paper: Association between suicide attempts and selective serotonin
reuptake inhibitors: systematic review of randomised controlled
6, 2004: No evidence that SSRI antidepressants likely to increase
suicidal behaviour, watchdog announces - NICE guidelines also
issued for treatment of depression
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