Seroxat banned for under-18s

June 14, 2003 - Source: http://society.guardian.co.uk

The future of Britain's best-selling antidepressant drug, Seroxat, and the rest of the class which includes Prozac, was last week after drug regulators banned its use in under-18s.

New evidence handed to the medicines and healthcare products regulatory agency (MHRA), which licenses and monitors drugs, by Seroxat's manufacturer, GlaxoSmithKline, demonstrated that it can cause young people to become suicidal.

In trials, 3.4% of children on the drug experienced mood changes, tried to harm themselves or thought of committing suicide, compared with 1.2% on placebo pills. Some of the data came from studies completed in the late 1990s, and the regulator is unhappy Glaxo has not felt the need to pass it on until now.

There were 4m prescriptions written for Seroxat last year. It is considered one of the wonderdrugs of modern times and has been handed out for shyness and compulsive disorders as well as for anxiety and depression.

But doctors were told that yesterday that children must no longer be given it. The 8,000 now on it must not stop suddenly, experts warned, because of potential side-effects, but should see their doctors. GPs will be advised to arrange counselling for young people instead, even though it is expensive and in short supply on the NHS.

The MHRA announcement was a swift and unexpected response to clinical trial data handed over by the British drug giant Glaxo just two weeks ago. The company gave the agency a meta-analysis of nine separate studies of the drug in children and young people which it had commissioned since the late 90s. Only one had been published.

The studies were designed to gather information on the efficacy and safety of Seroxat in children with three different illnesses - major depression, social anxiety disorder and obsessive compulsive disorder - in the hope of winning a licence to market the drug for those conditions in the US and Europe. At the moment Seroxat is unlicensed for children, but doctors may and do prescribe it to under-18s on their own authority.

According to Alastair Benbow, Glaxo's head of European psychiatry, the trials on a total of 1,697 under-18s found that the drug was effective for social anxiety disorder and obsessive compulsive disorder, but not for depression.

He said the company had submitted the analysis of the nine trials to the MHRA as a matter of routine. It had not supplied the results of each trial as it finished. "We provide information as a package," he said.

There had not been a clear signal from any one trial that there might be a problem, he said, and so there was no reason to give the MHRA earlier information.

"Not unless we think there is something that needs attention, and we did not," Dr Benbow said. He added that Glaxo did not agree with the MHRA's interpretation of the data, and insisted there was no evidence the drug could make adults suicidal.

But an expert working group was set up by the MHRA this year to look at the possible side-effects of all the drugs in this class, known as the selective serotonin re-uptake inhibitors.

At an MHRA briefing yesterday its chairman, Alastair Breckenridge, said the group would "urgently examine what are the implications if any of these new findings in children and adolescents for the use of Seroxat in adults, and what are the implications for the other SSRIs."

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What psychiatrists say.....

A spokesperson for the Royal College of Psychiatrists said: "The Royal College of Psychiatrists welcomes the clear advice from the Medicines and Healthcare Products Regulatory Agency banning the use of Seroxat in children and adolescents under the age of 18 in the treatment of depressive illness.

"We shall ensure that this advice is disseminated to our membership promptly.

"Depressive illness in children and adolescents is a very serious illness which has been under-recognised for many years and which presents a considerable challenge. There is some suggestion that the failure to treat depression in children may lead to life-long disabilities and disturbed relationships.

"The College believes that it is vital that more research is carried out in this area.

"Currently the National Institute for Clinical Excellence has asked the National Collaborating Centre for Mental Health to undertake a full review of the treatment of depression in children. Work is already underway and will be reporting in 2004. The Collaborating Centre (which includes the Royal College of Psychiatrists’ and British Psychological Society’s Research Units) will be reporting very early next year on the use of the drugs and the treatment of depressive illness."

What MINDs says...

A MIND spokesperson said: "Mind has questioned the power and control of the MHRA over the drugs industry.

"The key question the charity wants to ask is how pro-active the regulator is, or is empowered to be, in seeking clinical trial data from the drug companies and whether the current system of regulating ‘off-label’ prescribing is adequate.

"Mind is also pressing for an urgent review of the use of Seroxat for adults with depression. Mind had already called for Seroxat to be withdrawn from all new prescriptions for adults in the light of new evidence produced by Mind and Panorama. This data, based on patients reporting side effects themselves, showed that people who were taking the drug experienced increased suicidal thoughts and behaviour.

"The charity’s other big concern is the acute lack of alternative non-drug treatments for under-18s with depression; there is a severe shortage of trained psychologists and other professionals able to offer cognitive behavioural therapy and other counselling to children and young people. It is this shortage of alternatives that leads to many children being prescribed anti-depressants in the first place.

Note: Richard Brook, Mind’s chief executive, is a member of the Expert Working Group set up by the MHRA to review SSRIs.

See also:
June 8: Coroner hedges on whether Prozac drove woman to suicide - but David Healy, director of the North Wales department of psychological medicine, says people can become suicidal on SSRIs.
May 24: Chair of Medicines and Healthcare Products Regulatory Agency welcomes new inquiry into SSRI's

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