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Last Updated: Thursday, 6 March 2008, 13:48 GMT
Q&A: Seroxat data
Seroxat was the first SSRI to be banned in under 18s
Laws on disclosure of trial data by drug companies are to be toughened up after GlaxoSmithKline were accused of being too slow to raise the alarm over Seroxat and the risk of suicidal behaviour.

What is Seroxat?

Seroxat, made by GSK, is one of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

The drugs work by increasing levels of the mood controlling chemical serotonin in the brain.

SSRIs recently hit the headlines after a study found they had no more effect than a dummy pill for people with mild or moderate depression but seemed to have more benefit for people with severe depression.

What is the problem with antidepressant use in children?

In May 2003, the Medicines and Healthcare products Regulatory Agency (MHRA) received data from GSK confirming that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat compared with placebo.

The data also showed that Seroxat was ineffective in treating depressive illness in under 18's.

Within weeks, the MHRA issued guidance to doctors not to prescribe the drug in under 18s.

By the end of 2003, that warning had been widened to all other SSRI antidepressants after experts found no, or insufficient, evidence from clinical trials that benefits outweigh the risks of side effects.

Only one, Prozac, was recommended for patients under 18 with severe depression.

Did drugs companies withhold information?

The MHRA subsequently launched an investigation to look into claims that GSK had known about the risks for some time before it had disclosed it.

Investigations by BBC's Panorama showed the company may have first known about problems with the drug in the late 1990s.

After reviewing more than one million pages of evidence the MHRA said no criminal proceedings could be brought against GSK because legislation on disclosure at the time was not strong enough.

But they "remain concerned" that GSK could and should have reported the information earlier than they did.

Should drug company trial data be publicly available?

Critics of the current system say drug companies should be compelled to publish all trial data, regardless of whether it shows their products in a positive or negative light.

At the time the Seroxat trials were being done in children, drug companies were not required to inform the MHRA of safety information when the drug was being used for, or tested outside its licensed indications.

In common with many drugs, Seroxat was not licensed for use in the under 18s, although doctors were able to prescribe it.

What is being done?

The government has promised to strengthen laws on drug trial disclosure through changes to the EU Directive and amending the law as it applies in the UK.

Letters are being sent from the MHRA to all pharmaceutical companies to make it clear that, notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health.

What do GSK say?

The drug company say they carried out nine trials in under 18s but did not find any "clinical meaningful" risk associated with the Seroxat in individual studies.

It was only when the analysed all the data together, the increased risk of suicidal behaviour became apparent.

Dr Alastair Benbow, medical director for GSK Europe said the company is committed to ensuring that all appropriate information is made available to regulators, doctors and patients.

He added the company "firmly believe" they acted properly and responsibly in first carrying out the clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk.


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