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The Pharmaceutical Journal Vol 272 No 7287 p214 21 February 2004	This article Reprint Photocopy
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Medicines in children

Concerns over Government advice not to use SSRIs in children

From Ms A. H. Sutcliffe, MRPharmS

The trustees and members of Papyrus (Prevention of Suicides) wish to express their concerns following the Government’s advice that most selective serotonin reuptake inhibitors should not be used to treat moderate or severe depressive disorder in children and adolescents under the age of 18 years (with use in 18–20 year olds to be reviewed) (PJ, 13 December 2003, p803). This advice, from the Medicines and Healthcare products Regulatory Agency and the Committee on Safety of Medicines, follows the review of data from clinical trials by an expert working group, convened initially because of concerns that SSRIs may increase the risk of suicidal thoughts and self-harm in young people. The review concluded that the risk/benefit balance is unfavourable for all SSRIs apart from fluoxetine.

Little research has taken place on the use of these drugs in young people and the 40,000 or so children taking them in the UK are doing so on the basis of evidence from a few hundred people.

There are two major issues:

· The distress of many of our members that these drugs have continued to be prescribed for a considerable period despite increasing evidence of adverse side effects being reported by parents and carers
· The problem as to what treatment will now be available; NHS waiting lists for alternative treatments such as counselling and cognitive behavioural therapy are long in most areas

A high proportion of these young people will now be treated with fluoxetine on the basis of relatively small trials. More independent research is necessary.
It is the policy of Papyrus not to be confrontational in raising this issue, but we should appreciate answers to the following questions:

· What can be learnt from these regrettable side effects? Has any attempt been made to audit adverse reactions and determine whether they could be caused by some or all of the following: severity and subtype of depression, incorrect diagnosis, inadequate monitoring and supervision, prescribing practice (eg, multiple prescribing) or inappropriate dosage?
· What is being done to keep the issue of SSRIs and young people under review and further assess the risk/benefit ratio?
· Have there been any studies and monitoring in relation to findings in other countries?
· Will there be rapidly increased provision of alternative treatments?

It is possible that withdrawal of these drugs could lead to increasing numbers of suicides caused by the lack of suitable treatments. Despite potentially adverse reactions, SSRIs are known to help many people suffering clinical depression and the carefully controlled use of these drugs may still be the treatment of choice until much needed better, safer treatments are developed.

Anita Sutcliffe
Trustee
Papyrus

GORDON DUFF, chairman, Committee on Safety of Medicines, responds:

Ms Sutcliffe asks whether the suspected adverse reactions in children might be related to severity and subtype of depression, incorrect diagnosis, inadequate monitoring and supervision, prescribing practice or inappropriate dosage. The clinical trials on which the CSM advice is based were designed to demonstrate efficacy and safety of the SSRIs in depressive illness and factors such as diagnosis of depressive illness, monitoring of patients and titration of dosage were taken into account in the design of the studies. Summaries of the evidence on which the CSM advice was based have been published on the CSM web pages

The expert working group established by the CSM to review the safety of SSRIs is considering a number of sources of information, including reports from patients and carers. The MHRA works in close co-operation with other regulatory authorities within the EU and has regular contact and exchanges of information with other authorities around the world.

Recommendations as to the provision of alternative treatments for depressive illness fall outside my remit as chairman of the CSM. I am aware that the National Institute for Clinical Excellence is preparing guidelines.

The CSM and its expert working groups are keeping the use of SSRIs in children under review and will consider any new information that arises. This matter highlights our limited knowledge about the safety and efficacy of medicines in children. The CSM and its expert working group on paediatric medicines are continually working to increase the awareness of the need for more studies and to improve the availability of licensed medicines for children.

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