March 21, 2004

The chief executive of the Medicines and Healthcare Products Regulatory Agency has criticised the director of mental health charity MIND for provoking "alarm" and "confusion" after he accused a Committee on Safety of Medicines group of negligence over its investigations into SSRI antidepressants.

MIND's Richard Brook resigned from a Committee on Safety of Medicines (CSM) expert working group reviewing SSRI antidepressants after claiming the group knew about concerns over Seroxat for 10 years but took no action.

The CSM advises the Medicines and Healthcare Products Regulatory Agency (MHPRA) which licenses drugs for use in the UK

Mr Brook, a lay member of the working group, accused the MHPRA of failing in its duty by not acting on data showing that thousands of people were taking unsafe doses of Seroxat.

But MHPRA's chief executive Prof Kent Woods has responsed by denying that information was supressed.

Prof Woods wrote to the Guardian newspaper saying it was "regrettable" that Mr Brook's claims may cause "alarm and confusion among vulnerable patients by presenting his opinion as if it were suppressed fact."

The CSM warned doctors a fortnight ago 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.

The MHPRA is also presently investigating concerns that Seroxat can be addictive and increase the risk of violent behaviour in some adults.

Prof Woods said: "Patients are entitled to clear, consistent advice based on thorough evaluation of all evidence. The guidance issued by the CSM reminded doctors of the starting dose recommendation which has been in place since the drug was licensed.

"Brook's use of emotive language such as 'negligence' and 'gagging' does an injustice to the months of careful review of the evidence on this class of drug which has been carried out by the CSM's expert working group on safety of SSRIs, and which has been clearly communicated and explained to doctors and patients at each stage."

See:
March 15: MIND's chief executive resigns from expert group reviewing safety of antidepressants - Richard Brook accuses regulatory agency of negligence

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