§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)Following interest in both Houses about the issues surrounding the safety of selective serotonin re-uptake inhibitors (SSRIs), this Statement informs the House of the completion of the United Kingdom review of SSRIs and the publication today of the report. The Committee on Safety of Medicines (CSM) expert working 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 depressive illnesses the information they need to make informed decisions about treatment of these potentially devastating conditions.
In 2003 an expert working group of the CSM was set up to consider further the safety of SSRIs, with particular reference to suicidal behaviour and withdrawal reactions. The expert group has examined all the evidence available from a wide range of sources, including a specific objective to listen to the patient viewpoint. The expert group has already reached conclusions on the use of SSRIs in children and the Government have published its findings. This latest report focuses on the use of SSRIs in adults. The work of this group is now complete and a comprehensive account of this work is being published today. In short, it concludes that:
- there should be strengthened warnings on coming off SSRIs at the end of a course of treatment and how to minimise the risk of experiencing a withdrawal reaction;
- there should be specific advice on using the recommended dose of the SSRI because for the
WS 50 majority of SSRIs in depression, clinical trial data do not show an additional benefit above the lowest recommended dose; - there should be clearer advice on what is known about the risk of suicide and suicidal behaviour—while clinical trial data cannot rule out a modest increase in the risk compared to placebo, there is now good evidence from large population studies that there is no clear increase in the risk of suicide in relation to SSRIs compared to other antidepressants;
- there is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over. But individuals mature at different rates and young adults are at a higher background risk of suicidal behaviour than older adults, so as a precautionary measure young adults treated with SSRIs should be closely monitored. The expert group also recommended that in further research on the safety and efficacy of SSRIs young adults should be assessed separately.
The CSM has also recommended that treatment with venlafaxine (Efexor) should only be initiated by specialists and that there should be in place arrangements for ongoing supervision of the patient.
The report includes the key evidence on which the advice of the expert working group is based, including summaries of clinical trials submitted by companies at the MHRA's request. This unusual step demonstrates the MHRA's commitment to being as open as possible in drug regulation.
The report of the expert group is being published alongside guidelines from the National Institute for Clinical Excellence (NICE) on depression and anxiety. In this way, the new advice of CSM can feed directly into clinical practice. Copies of the expert group's report and the NICE guidelines have been placed in the Library.
Communications to patients and prescribers are taking place today and copies of these materials have also been placed in the Library. SSRIs are an important group of medicines, which help patients who suffer depressive illness. The health 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.