December 14, 2003

Doctors should not prescribe selective serotonin reuptake inhibitors antidepressants (SSRIs) to under 18s, the Medicines and Healthcare products Regulatory Agency has announced

The new advice follows a review by a Committee on Safety of Medicines expert group set up earlier this year to look at the safety of SSRIs.

The group found that risks of treating depressive illness in under 18's with certain SSRIs outweigh the benefits of treatment.

The agency announced there is no, or insufficient, evidence from clinical trials that benefits outweigh the risks of side effects for sertraline (Lustral), citalopram (Cipramil), escitalopram (Cipralex) and fluvoxamine (Faverin). Fluoxetine, or Prozac, appears to have a positive balance of risks and benefits in the treatment of depressive illness in the under 18s.

However, some psychiatrists have doubts about the new advice.

At an online forum, doctors.net.uk, one consultant psychiatrist advised colleagues: "We have to ignore the rubbish being put about SSRIs.

"Keep patients and families fully informed and prescribe in the best interests of the patient, not the interests of DoH legal advisers. There is only one class of drugs to avoid in young patients - tricyclics."

Although another consultant psychiatrist contributing to the same forum appeared to support such a view, it is unlikely the psychiatry profession as a whole would go against the new advice.

An estimated 30 - 40,000 thousand children and teenagers are prescribed SSRI's across the UK. About half of those were treated with fluoxetine (Prozac).

In June, a warning was issued about the use of paroxetine (Seroxat) in children under the age of 18. Further advice was given in September about the use of venflaxine (Efexor).

Professor Gordon Duff, chairman of the Committee on Safety of Medicines (CSM), said: "The CSM Expert Group has delivered comprehensive advice on the use of these drugs in children and young people following a thorough review of all the evidence available.

"Like Seroxat and Efexor, none of these drugs has ever been licensed for use in those under 18.

"We know, however, they are used in this age group outside of their licensed indications where prescribers make a judgement on their own responsibility that it is the correct treatment for a particular patient."

In a new step, data from the clinical trials on SSRIs and children, supplied by the drug companies to the expert group, is also being released to allow clinicians to assess the information on which the new advice is based.

The Committee on Safety of Medicines group is now focusing on the ongoing review of the efficacy and safety of SSRIs in adults. This should be completed in the first half of next year.

Professor Ian Weller, chairman of the working group, said: "We are now working on completing the review of the safety of these medicines in adults. This is one of the most comprehensive reviews of a class of medicines ever to be undertaken and it is painstaking work, examining evidence from literally hundreds of clinical trials but we are determined to see this important work through.

"It should be complete in the spring. In the meantime, there is no evidence to suggest that the risks of treatment outweigh the benefits in adults."

See:
Medicines and Healthcare products Regulatory Agency's advice on SSRIs and children sent to psychiatrists and other mental health professionals (pdf)

See also:
Dec 10: Drugs for depressed children banned - the Guardian

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