The Committee on Safety of Medicines (CSM) has evaluated new data, which show there is an increase in the rate of self-harm and potentially suicidal behaviour when Seroxat is used to treat depressive illness in children and adolescents.

The CSM says it has become clear that the benefits of using Seroxat on children do not outweigh the risks.

The drug, which is a selective serotonin reuptake inhibitor (SSRI), was first licensed in the UK in 1990. In the last year, approximately 4 million prescriptions were written and Seroxat was given to an estimated 8,000 patients under 18.

Questions about the safety of SSRIs have been raised in the media over the past few years, most recently in a BBC “Panorama” programme, which was screened at the end of last year. Following such concerns, the CSM set up an expert group to look at the drugs, and this met for the first time in May.

CSM Chair Professor Gordon Duff said, “Seroxat is not licensed for use in children, but we know it is used in this age group outside its licensed indications where prescribers make a judgement on their own responsibility that it is the right treatment for a particular patient.

“It is therefore important that doctors, patients and parents are aware of the new advice,” he added. “Young people under 18 years currently taking Seroxat for depression should consult their doctor.”

The Department of Health says children or adults taking the drug should not suddenly stop the treatment and that any changes should take place under medical supervision.

Professor Ian Weller, chair of the CSM’s expert group looking at SSRIs, said the panel would be examining the implications for adults. But he added there was not enough evidence to confirm a causal link between Seroxat and suicidal behaviour in adults.

“The benefits of taking Seroxat are well established and patients over 18 years and those who are benefiting from Seroxat should not be frightened into stopping their medication,” he said.

MIND Chief Executive Richard Brook, who is also a member of the expert group, said the new evidence underlined some young users’ concerns about the drug.

“MIND strongly believes that the decision today requires us to move very quickly forward on the review of Seroxat and other SSRIs especially given the strength of concern we’ve heard from people taking these drugs,” he said.

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