Drugs regulator quick to remind doctors that it believes SSRI antidepressants are safe

February 21, 2005
by Angela Hussain

The UK drug regulator was quick to remind doctors last week that its research finds that, on balance, SSRI antidepressants are safe.

The reminder was published on the website of the Medicines and Healthcare products Regulatory Agency (MHRA).

It 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.

Bmj.com (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.

They found significantly higher probabilities of suicide attempts for patients on SSRIs than placebos.

The meta-analysis did not detect a difference between SSRIs and tricyclic antidepressants.

They said that a number of major methodological limitations of the published trials may have led to underestimates of the risk of suicide attempts.

A second study published by Bmj.com was carried out by the department of epidemiology of Bristol University.

It looked at data from 477 published and unpublished trials submitted to the MHRA by the pharmaceutical companies for the recent MHRA review of the safety of the SSRIs.

It 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.

The third study compared people put on SSRIs by their GP for the first time with those given the tricyclics.

It found no difference in the number of suicides and episodes of self-harm.

Responding 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.

Prof Ian Weller, chair of the expert working group, said: "The group conducted the largest review ever of evidence relating to SSRIs.

"We considered a huge range of evidence, both published and unpublished, including the studies published in the British Medical Journal.

"Whilst 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 its recommendations."

Prof 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."

Read for yourself:
The MHRA's December 2004 advice on SSRIs for healthcare professionals

.....

Bmj.com 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

Bmj.com paper: Antidepressant treatment and the risk of fatal and non-fatal self harm in first episode depression: nested case-control study

Bmj.com paper: Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials

See also:
Dec 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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