Call for temporary ban on paroxetine
The Government's expert inquiry into the safety of selective serotonin reuptake inhibitors has been urged to issue a temporary ban on prescribing paroxetine (Seroxat) to all patients amid new claims that even small dose changes can 'precipitate potentially dangerous mental turmoil'.
The fresh evidence on dosage changes came as the Committee on Safety of Medicines expert working group commissioned its own analysis of GP records examining possible links between
SSRIs and suicide, or suicidal thoughts and behaviour.
Professor Andrew Herxheimer, emeritus fellow at the UK Cochrane Centre in Oxford, presented new research to the group at its July meeting showing flaws in the Yellow Card scheme have led to a potentially fatal underestimation of the risk of suicidal behaviour associated with paroxetine.
Professor Herxheimer, a clinical pharmacologist, has told the inquiry that patient reports showed that changes in dosage could 'precipitate potentially dangerous mental turmoil'.
He said he was 'struck by the complete lack of coherent science-based advice on dosage'.
His analysis of 91 Yellow Cards reporting problems with paroxetine showed that at least half relating to suicide, attempted suicide, parasuicide or suicidal ideation were associated with changes in drug concentration in the body during the first week of treatment or with dose increase or severe symptoms related to drug withdrawal.
He warned a lack of prescribing information meant that patients were routinely given too high a dosage of the drug and that GPs readily increased dosage when patients initially complained they felt worse.
He called on the CSM to temporarily ban doctors from prescribing paroxetine to new patients until better information on adverse effects is available.
Professor Herxheimer said: 'This association has previously been missed.'
The study, published in the International Journal of Risk and Safety in Medicine (September), said: 'People on the drug need much closer monitoring by doctors and need to be informed much better before they are given it.'
A spokesman for GlaxoSmithKline, which manufactures Seroxat, said: 'No treatment is perfect for every individual patient and it's a matter for the doctor, in conjunction with the patient, to decide exactly what is the best treatment for them.'
Professor Herxheimer is calling for the manufacturer to provide paroxetine in smaller doses:
'The tablets only come in 10mg or 20mg and a lot of people need smaller doses, especially when they are withdrawing,' he said.