Child warning on anti-depressants

Professor Gordon Duff
Mental health groups have criticised the regulatory process, expressing concern that thousands of children have been allowed to take drugs that may have done them harm.

The expert group found there is no, or insufficient, evidence from clinical trials that benefits outweigh the risks of side effects for the following SSRIs (selective serotonin reuptake inhibitors):

sertraline (trade name Lustral)
citalopram (Cipramil)
escitalopram (Cipralex)
fluvoxamine (Faverin)

The experts recommended that just one SSRI - fluoxetine (Prozac) - should continue to be prescribed for people under 18. It was the only drug that had clearly demonstrated that the benefits outweighed the risks.

Professor Ian Weller, chairman of the working group, told the BBC: "The evidence is that the drugs either don't work, or work only very little, and there are large number of side effects that children get, such as headache, shaky hands, agitation, loss of appetite, loss of weight."

Taken by many

It is estimated that up to 40,000 children and teenagers are prescribed SSRIs across the UK. About half of those are treated with Prozac.

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

The latest advice completes the picture on the remaining five SSRIs.

Professor Weller said there were many side effects
Professor Gordon Duff, Chairman of the Committee on Safety of Medicines, said that, like Seroxat and Efexor, none of the drugs considered by the expert group had 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.

"It is therefore important that patients, parents and doctors are aware of the new advice.

"Young people with depressive illness currently taking any SSRI other than fluoxetine should not stop taking their medicine but should consult their doctor for advice on treatment".

  Long-term, effective and strong regulation has not been in evident in this case or provided the type of information consumers have the right to expect.  

Richard Brook
Data from the clinical trials on SSRIs and children - supplied by the drug companies to the expert group - is being released today to allow doctors to assess the information on which the new advice is based.

Professor Weller said it would now focus on the use of SSRIs in adults.

But he added: "In the meantime, there is no evidence to suggest that the risks of treatment outweigh the benefits in adults.

"Patients who are experiencing any side effects or are concerned about their treatment should discuss these with their doctor."

Drugs companies have challenged the expert group's findings.

Dr Kate Lloyd, of Pfizer, told the BBC: "There is no excess of risk. We disagree with this interpretation of the data."

Independent review needed

The mental health charity Mind called for an independent review of drug regulatory process.

Chief executive Richard Brook said: "It is totally unacceptable that for a significant period 50,000 children and adolescents in the UK have been prescribed anti-depressant drugs that were not licensed for use but it is only now being demonstrated that they do not help and can indeed cause harm.

"Long-term, effective and strong regulation has not been in evident in this case or provided the type of information consumers have the right to expect."

Mr Brook expressed concern about the influence of the powerful pharmaceutical lobby, and criticised the expert group for taking more than nine months to come up with its conclusions.

"The public needs to have confidence that their health is being properly protected - particularly where children are concerned - and I do not believe we have a process in place at present that ensures this is not happening."

Marjorie Wallace, chief executive of the mental health charity SANE, acknowledged that some new anti-depressants can have disturbing side effects on children and adolescents.

However, she said: "Because of the huge lack of psychologists and others able to provide alternative help, withdrawing these drugs will leave many families struggling without the chance of treatment and left, often in desperation, to cope as best they can."