Agency blamed for promoting Seroxat / Paxil

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08/05/03 - Health news section

 

Agency blamed for promoting Seroxat

 

The body which regulates medicines is playing Russian Roulette with people's

lives over the common antidepressant drug Seroxat, a charity claimed today.

Mental health charity Mind said the Medicines Control Agency - now the Medicines

and Healthcare products Regulatory Agency - had failed in its duty as the body

responsible for the safety of prescribed drugs.

Seroxat, which is manufactured by GlaxoSmithKline, is one of the most commonly

prescribed antidepressants.

 

But some who have taken it have claimed they became hooked on the drug, while

others have reported feelings of self harm, or even suicide.

Mind chief executive Richard Brook said the MHRA had not listened to the

experiences of people who had taken Seroxat.

 

" Many of these people have suffered terrible side effects when taking or trying

to come off the drug and some people, it is believed, have died, " he said.

On Monday, Mind and people who have taken Seroxat, will protest outside the

offices of the MHRA in London.

Mind is calling for Seroxat not to be issued for new prescriptions until a full

and independent inquiry has been conducted involving people who have taken the

drug.

 

The charity is demanding urgent meetings with health minister Hazel Blears,

GlaxoSmithKline, and the Royal Colleges of GPs and Psychiatrists. It also wants

discussions about stronger warnings of potential side effects on information

leaflets and better training for doctors.

 

In October the documentary series Panorama raised concerns about Seroxat and the

BBC was contacted by thousands of people who had taken the drug. Of these, 239

agreed to take part in a survey about their experiences.

 

Some 97% reported unwanted side effects and 50% of these said they had had

feelings of self harm or suicide.

Withdrawal problems were experienced by 83%, while 66% of those who tried to

stop taking the drug said they felt unable to do so. Of the 55% who asked their

doctor about side effects, 31% had been told there were no side effects and 39%

were informed that the drug was not addictive.

 

Currently members of the medical profession can report adverse drug reactions to

the MHRA's yellow card scheme.

But Mr Brook said the BBC had received more reports of problems than the

official yellow card scheme. He called on the MHRA to promote its yellow card

scheme more widely. mfl

A spokeswoman for GlaxoSmithKline said since its launch Seroxat had helped tens

of millions of people worldwide with depression to lead fuller and more

productive lives.

 

She also said suicide was a potentially avoidable consequence of depression, and

Seroxat could therefore help prevent it.

 

" This is probably one of the most extensively investigated medicines that is

available in the UK today and like all medicines is subject to continuous

ongoing safety monitoring, " she said. " Information from patients about how they

have responded to treatment and the impact the treatment has on them is

extremely important and is something that GSK takes very seriously. "

 

She added that for patients the most important source of information was their

doctor as he or she knew the individual's background and what was the best

treatment for them.

 

 

 

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