Seroxat makes adults suicidal too

By Panorama reporter Shelley Jofre

It is four years since Panorama started investigating Britain's best-selling anti-depressant, Seroxat which is also known as paroxetine.

GlaxoSmithKline (GSK) makes the drug and has finally been forced to admit that the medication can make adults, as well as children, suicidal.

Panorama first broadcast claims that Seroxat could provoke self-harm, aggression and suicide in October 2002 in Secrets of Seroxat.

Read GlaxoSmithKline's statement

That programme prompted an official inquiry into the drug and a flood of responses from our viewers, many of whom said they had experience similar problems while on Seroxat.

Their evidence formed the basis for our second programme Seroxat: Emails from the Edge.

Panorama was first to reveal evidence that GSK's own trials of Seroxat on children showed the drug was making some suicidal. Afterwards, the Medicines and Healthcare Regulatory Agency (MHRA), banned the drug's use in under-18s.

This latest twist in the story comes as a result of a re-analysis of GSK's clinical trial data, ordered by the US medicines regulator, the Food and Drug Administration (FDA).

Here in Britain, the MHRA has until now steadfastly refused to admit that Seroxat can cause suicidal behaviour in adults. Speaking about the third of our investigations into the subject, Taken on Trust (October 2004), the chairman of the MHRA Alasdair Breckenridge told us:

"In the adult population the drugs are effective. There are over 300 studies which have been analysed and studies using epidemiological databases the drugs do not cause suicide, they do not cause suicidal thought."

Now that GSK acknowledges its own data shows the drug can cause suicidal behaviour in adults, it has led to criticism that the MHRA has failed to listen to patients' complaints and to protect public health. Professor David Healy, who first raised his concerns about Seroxat with the regulator seven years ago, said:

"I think in due course we may look at all of this and think this was one of the biggest medical scandals ever.

"The risk of suicidal behaviour in placebo controlled trials in all adults was over six fold higher on Seroxat than on placebo.

"This completely contradicts the information GSK gave to the MHRA within the last three years.

"GSK now say they have spotted the risk thanks to the help of outside experts. The MHRA had outside experts also.

"One of the things that has changed is that until very recently GSK and the MHRA were agreed that there were three placebo suicides in the Seroxat placebo controlled trials. There weren't. This was a fiction. None of the experts bothered to check out the implausibility of these suicides. Neither did the MHRA.

"There is nothing about this story that could reassure anyone about pharmaceutical companies or the regulator."

An estimated 300,000 people in Britain were prescribed Seroxat last year. It is GSK's biggest-selling drug, earning the company billions of pounds since its launch in 1991.