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Mental health  |  The NHS plan

Drugs watchdog 'ignored dangers'

Jo Revill, health editor
Sunday March 14, 2004
The Observer

A full and independent review into how new drugs are assessed for their safety has been called for by a charity director who has quit over an alleged cover-up.

Richard Brook, the head of Mind, spoke out after resigning from a review of anti-depressants, as he accused a government drugs watchdog of negligence. He claims the Medicines and Healthcare Products Regulatory Agency (MHRA) knew about the concerns over Seroxat for 10 years but took no action.

A lay member of its working group investigating the class of drugs called Selective Serotonin Reuptake Inhibitors (SSRIs), of which Seroxat is one, he accused the MHRA - which licenses drugs for use in the UK - of failing in its duty by not acting on data showing that thousands of people were taking unsafe doses of Seroxat.

The information only came to light last Thursday when the Committee on Safety of Medicines, which advises the MHRA, warned doctors to keep to 20mg when prescribing the drug to new patients with most types of disorder. Around 17,000 people were given higher doses last year, which could increase the risk of side-effects such as insomnia and nausea.

Doctors have also beenwarned that children and under-18s should not be prescribed Seroxat, which can be addictive and increase the risk of violent behaviour and suicide in some people.

'On Thursday the agency at last published information advising that many thousands of men and women in this country may have been taking Seroxat at a dose that was unsafe,' Brook said. 'What it failed to mention is that the regulator had the data on which the basis of this decision was made for well over a decade as part of the original licence application.

'Either they didn't understand the full implications of the available medical data at the time or, worse, that data was fully understood and they failed to act.'

The Department of Health said: 'The MHRA is aware of Mr Brook's concerns, but denies any cover-up.'

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