Mind chief resigns and accuses MHRA

Mental Health Nursing,  May 2004  by Brook, Richard

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The MHRA has announced that initial dosages of Seroxat should by 20 mgs. The MHRA Committee on the Safety of Medicines and its Expert Group on selective serotonin reuptake inhibitors' (SSRIs) guidance follows a 'reanalysis' of the available data and new evidence showing the extent to which new patients have been started on higher than the recommended dose.

Mr Brook has also tendered his resignation from the Expert Group stating that continued membership is incompatible with Mind's remit to represent the interests of mental health service users.

He said: 'The Agency (has) 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. What they failed to mention - and what I am now making public - is the fact 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 license 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. Either way it amounts to extreme negligence and a clear dereliction of the MHRA's duty to safeguard the well-being of the British public.

'Drugs regulation simply has to put patients' interests first. We will continue to press the MHRA to release any information that is in the direct interests of consumers promptly and fully and we are restating our previous calls for a full and independent review of UK drugs regulation.'

The CSM and its Expert Working Group reviewed again all the clinical trial data for Seroxat and announced that a reminder to prescribers was necessary to ensure that health professionals continued to prescribe the drug consistent with existing safety advice.

The reminder states:

* the starting dose of paroxetine in the treatment of depression should be 20mg, as per the current Summary of Products Characteristics (SPC)

* there was no evidence from clinical trials of increased efficacy in the treatment of depressive illness above 20mg.

* the adverse events that occur soon after starting therapy may be difficult to distinguish from the underlying condition. There is evidence that increasing the dose in this situation may be detrimental.

* rapidly increasing the dose could heighten the risk of serious adverse events.

* those currently on a higher dose and responding well to treatment should remain on the same dose and be reviewed at their next regular treatment review.

* patients should not stop treatment suddenly, but should consult their doctor and reduce their dose gradually.

The chairman of the CSM, Professor Gordon Duff, said: The CSM has issued this important reminder following a reanalysis of the available data and new evidence showing the extent to which new patients have been started on higher than the recommended dose. '

Health Minister, Lord Warner said: 'It's important to ensure that health professionals are reminded to follow the recommended safe dosage for patients receiving Seroxat for the first time so that patient safety is not compromised. The decision to issue this reminder was taken following a thorough review by the CSM of the available evidence, and will help to make sure that doctors and patients are able to choose the right treatment.'

The Expert Working Group is continuing its work to conclude its full review of the safety and efficacy of SSRIs and will examine what implications, if any, these latest findings have for the use of other SSRIs.

Richard Brook, chief executive of Mind, has resigned from the Medicines and Healthcare Products Regulatory Agency (MHRA) accusing it of failure to protect consumers from potentially harmful doses of antidepressant Seroxat (paroxetine).

Copyright Community Psychiatric Nurses Association May 2004
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