Review findings released on the safety of antidepressants (SSRI's)

Dec 6 2004

The Medicines and Healthcare products Regulatory Agency (MHRA) issued new advice to patients and doctors about the group of antidepressants known as SSRI's, today.

The updated advice follows the biggest and most thorough review of Selective Serotonin Reuptake Inhibitors (SSRI) antidepressants, by an independent group of medical experts. The review, which examined hundreds of clinical trials, was set up to look at the safety of SSRIs, with a particular emphasis on possible suicidal behaviour and withdrawal reactions.

The review findings are:

• There should be strengthened warnings about the risk of experiencing withdrawal reactions at the end of a course of treatment with SSRIs

• In the majority of cases, the lowest recommended dose of SSRI's should be prescribed.

• From the available clinical trial data, both published and unpublished, a modest increase in the risk of suicidal thoughts and self-harm for SSRIs compared with placebo cannot be ruled out.

• There is good evidence from large population studies that there is no clear increase in the risk of suicide from SSRIs compared to other antidepressants.

• Careful and frequent patient monitoring by healthcare professionals and where appropriate other carers, is important in the early stages of treatment.

• Young adults should be closely monitored, as a precautionary measure, when being treated with SSRI's.

• The CSM also recommended that in further research on the safety and efficacy of SSRIs, young adults should be assessed separately.

The Committee on Safety of Medicines also recommended that treatment with venlafaxine (Efexor) should only be started by specialists and there should be arrangements in place for ongoing supervision of the patient. Patients with heart disease should not be given venlafaxine at all.

The new advice for stronger and clearer warnings in certain areas will result in changes to patient information leaflets with the medicines.

Professor Kent Woods, Chief Executive of the MHRA, said:

"The CSM Expert Group has now delivered comprehensive advice on the use of these drugs in children, young people and adults following a thorough review of all the evidence available. This gives parents, patients and those who treat these devastating and debilitating illnesses the information they need to make informed decisions about treatment.

"SSRIs are an important group of medicines, which help patients who suffer depressive illness. The benefits of SSRIs in adults are still considered to outweigh the risk of adverse drug reactions. Patients currently taking venlafaxine should not stop taking their medicine but should consult their doctor for advice on treatment as should patients taking other SSRIs who are experiencing any side effects or are concerned about their treatment".

Professor Louis Appleby, National Director for Mental Health, said:

"The CSM has delivered one of the most comprehensive reviews of a class of medicines ever to be completed and it has been painstaking work, examining evidence from literally hundreds of clinical trials. What's important now is that their advice is put into practice. Publication of the NICE guidelines gives us the tools to do the job so that patients and prescribers can together make the best informed decisions."