Modern anti-depressant drugs will be banned from use in children in Britain on Wednesday because of evidence, suppressed for years, that they can cause young patients to become suicidal.
The Medicines and Healthcare Products Regulatory Agency (MHRA) told doctors on Tuesday not to prescribe all but one of the anti-depressants known as selective serotonin reuptake inhibitors (SSRIs).
The exception is Prozac, which is licensed for use in depressed children in the US. But the MHRA will warn that, at best, it helps only one child in 10.
The decision has big implications for drug regulation.
The agency – the British government’s watchdog body on drug safety – has reached this point only after intense pressure from patients and campaigners.
They were concerned about patients – at first mainly adults – who appeared to have become suicidal on the drugs, and others who had got hooked and suffered distressing symptoms when they tried to stop taking them.
Public unease about these potential side-effects prompted the agency to investigate last year. It has looked at the details of clinical trials of depressed children that were in the hands of the drug companies in the late 1990s. These studies revealed the problem of suicidal behavior in children, but the companies did not draw it to the attention of the regulators in the US or the UK.
It has become clear from the investigation that the regulators generally see only a summary of the data resulting from trials. It is prepared for them by the drug company only when it is seeking a license.
The agency became aware of a problem with Seroxat in children this year only when the manufacturer, Glaxo Smith Kline, submitted data from trials which finished in 1996.
Two of the SSRI class of drugs have already been banned – or, technically, contra-indicated in children – by the agency
The first, in June, was Seroxat, which goes by the generic name paroxetine; the second, in September, was Efexor (venlafaxine); joining them now will be Lustral (sertraline), Cipramil (citalopram), Cipralex (escitalopram) and Faverin (fluvoxamine).
Trials on children have not been carried out in all the drugs, but the completed studies show a worrying increase in suicidal behavior among those on SSRIs compared with those given a placebo (sugar pill).
Guardian News Service