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Fwd: [SSRI-Research] Paxil: Unprecedented high-level warning to doctors and patients today

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JustSayNO

Tue, 10 Jun 2003 10:46:44 -0000

[sSRI-Research] Paxil: Unprecedented high-level warning to doctors and

patients today

 

Seroxat (Paxil) warning over risk to young

 

Suicidal feelings may be side effect for under-18s

 

Sarah Boseley, health editor

Tuesday June 10, 2003

The Guardian

http://www.guardian.co.uk/uk_news/story/0,3604,974175,00.html

 

An unprecedented high-level warning will go out to doctors and

patients today that Seroxat, the most commonly prescribed

antidepressant in Britain, could cause young people under 18 to

kill or harm themselves.

 

The warning from the head of the government's drug regulatory

agency, is a blow to the pharmaceutical companies that

manufacture antidepressants of the Seroxat class, which include

Prozac.

 

An acknowledgement that one of these drugs can cause young

people to feel suicidal will undermine the drug companies'

repeated assertions that they have no such effect on adults. Last

week the West Yorkshire coroner, sitting in Leeds, left open the

possibility that Prozac " may or may not " have contributed to the

suicide of librarian Wendy Hay.

 

The medicines and healthcare products regulatory agency

(MHRA), which licences drugs in the UK, is expected to take a

tough line with GlaxoSmithKline, the manufacturer of Seroxat,

when it announces the warning today.

 

The agency takes the view that Glaxo should have drawn its

attention earlier to clinical trials among children which showed

that some suffered damaging side effects. Some of the young

people on Seroxat became agitated, aggressive and suicidal, a

trend that was not matched among similar young people given a

placebo.

 

As with many other drugs, Seroxat does not have a licence for

use in the under-18s, but doctors widely prescribe it.

 

The MHRA intends to send clinical auditors to look at all the data

the company holds.

 

Yesterday Glaxo denied it had covered up studies suggesting

the drug could do damage to the under-18s.

 

" We have made available all clinical and safety data from the

paroxatine (Seroxat) paediatric studies in a timely manner, " it

said in a statement.

 

The data on the side effects of Seroxat on young people was

sent to a review set up by the committee on the safety of

medicines, whose experts advise the MHRA.

 

In February, the first working group investigating the safety of this

class of drug - known as SSRIs (selective serotonin reuptake

inhibitors) - was disbanded after revelations in the Guardian that

some of the members had shareholdings in Glaxo. The group

was recently re-formed.

 

Yesterday David Healy, the director of the North Wales

department of psychological medicine at the University of Wales,

who gave evidence to the group last year on the suicide risks for

some who take SSRIs, said that if young people were at risk, so

were adults.

 

" If there are cautions being put in place warning that the drug can

cause problems for children, it is clear that warnings should be

put in place for adults as well, " he said.

 

 

 

 

 

 

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