Fwd: [drugawareness] FDA in UK Confirms - Paxil Leads to Suicide, Etc., For Those Under 18

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atracyphd2

Tue, 10 Jun 2003 00:26:22 EDT

[drugawareness] FDA in UK Confirms - Paxil Leads to Suicide, Etc., For

Those Under 18

 

 

 

 

From the following article:

 

" If it were found that critical studies had not been available to regulators

then GSK could eventually face criminal charges under the Medicines Act.

 

" In a highly unusual move, a team from the Good Clinical Practice unit of the

Medicines and Healthcare Products Regulatory Agency (MHRA) will demand access

to all of GSK's files and studies on Seroxat.

 

" The decision to take this dramatic step was taken following the delivery to

the MHRA of nine studies of Seroxat that confirm the antidepressant can lead

to suicidal tendencies and other medical damage when administered to people

under the age of 18. "

_______________________________

 

Since Eli Lilly, the makers of Prozac, were found guilty of criminal charges

in a similar case in 1985 involving one of their drugs, Oraflex, that caused

139 deaths and all that got them was a $20,000 fine, I doubt that Glaxo is not

exactly shaking in their boots over this one.

 

But it does look as though England is waking up before the US on this

critical issue. I have only been sounding this alarm for 14 long years and how

many

have died needlessly in the meantime?

 

My book, Prozac: Panacea or Pandora? - Our Serotonin Nightmare, includes

every aspect of the research on the deadly potential of the Prozac family of

drugs, the SSRI antidepressants, and the terrible mistake we have made in the

serotonin hypothesis. Although the information has been available for years,

with

the first edition coming out almost a decade ago, we are just now beginning to

wake up to this drug-induced nightmare.

 

Some reporters have worked hard to get this information out. Others have

failed terribly with the lack of information leading to many deaths. Every

reporter in this country needs to ask themselves how many have died because they

did

not report enough on this issue.

 

Get this information to your local reporters immediately and insist that they

report it. But along with that insist that they warn about the serious

withdrawal and tell them to listen to me this time about coming off this drug

SLOWLY

in order to survive the withdrawal. All of that information is available on

my tape on how to get off safely entitled, " Help! I Can't Get Off My

Antidepressant! " at 800-280-0730.

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition For Drug Awareness

www.drugawareness.org

 

Office: 801-282-5282

Cell: 801-209-1800

________________________________

 

 

http://www.thisislondon.co.uk/news/business/articles/timid63975?version=1

 

 

Glaxo faces storm over Seroxat

Alex Brummer, City Editor, Daily Mail

9 June 2003

 

 

CLINICAL auditors from Britain's medicines control agency are expected to

descend on Glaxo-SmithKline this week amid concerns that the pharmaceuticals

group may have suppressed a series of negative studies on its key antidepressant

drug Seroxat, known as Paxil in the US.

 

 

In a highly unusual move, a team from the Good Clinical Practice unit of the

Medicines and Healthcare Products Regulatory Agency (MHRA) will demand access

to all of GSK's files and studies on Seroxat.

 

 

The decision to take this dramatic step was taken following the delivery to

the MHRA of nine studies of Seroxat that confirm the antidepressant can lead to

suicidal tendencies and other medical damage when administered to people

under the age of 18.

 

 

There has been extensive media coverage of the potential harmful effects on

young people of Seroxat, one of GSK's leading compounds. But until now the

company has declined to acknowledge any serious problems.

 

 

This week, however, it will be asked by the MHRA to contact general

practitioners, letting them know of the potential dangers to people under 18.

 

 

Sources at GSK confirmed that an amendment to the instructions carried with

Seroxat was under discussion with the authorities and an announcement would be

made shortly. There was no knowledge of the impending clinical audit.

 

 

Disclosure of the regulatory concerns about Seroxat, which contributes

£1.5bn-£2bn of annual turnover to GSK, is likely to lead to nervous selling on

the

stock market when it opens for business today. Glaxo shares have recovered to

1258p this year after falling below £10 in 2002.

 

 

Concerns that clinical practices may have slipped at Britain's flagship

pharmaceuticals group will put additional pressure on the company's chief

executive

Jean-Pierre Garnier, who is already under fire over his possible £22m

severance package.

 

 

A senior source at the MHRA told the Daily Mail that the decision to conduct

an audit at GSK was 'very, very unusual'. 'Normally we have a good

relationship with these guys and work closely together,' the source said.

 

 

If it were found that critical studies had not been available to regulators

then GSK could eventually face criminal charges under the Medicines Act.

 

 

Previous Good Clinical Practice audits have been carried out at second-line

pharmaceutical groups where research practices are sometimes less rigorous.

 

 

Members of the Committee on the Safety of Medicines, the licensing arm of the

MHRA, were disturbed when they saw the parallel Seroxat and placebo studies

recently submitted by GSK. They revealed a predilection to suicide, aggressive

behaviour and other psychosis in Seroxat users under 18, which were not

present in the placebo studies.

 

 

The belief is that a deep volume of research work showing 'contraindications

in children' could not have been carried out overnight and the appropriate

regulatory authorities should have been alerted much earlier - so appropriate

amendments could be made.

 

 

The big worry for GSK now is that the disclosure of the disquiet at the MHRA

and its offshoots could attract the attention of the Food & Drugs

Administration in the US, which works closely with the British regulators.

 

 

That could seriously damage GSK's reputation in the US, where it does much of

its business and where Garnier has his headquarters.

 

 

A spokesman for GSK said: 'We can confirm we are in discussion with the MHRA

regarding proposed updates of the product characteristics of Seroxat. However,

it is not appropriate to discuss this dialogue further until the outcome of

this review.

 

 

'Seroxat is an important medication for treatment of anxiety and depression,

and has been for more than 10 years. It has benefited the lives of millions of

people suffering with these serious conditions.'

 

 

A decision on the safety of Seroxat/Paxil, and other widely prescribed

anti-depressants like Eli Lilly & Co's Prozac, will be announced tomorrow,

according

to the UK Medicines Control Agency. 'We will be making an announcement about

Seroxat tomorrow but we're not saying anything in advance,' spokeswoman Alison

Langley said.

 

 

Glaxo refused to comment on whether a clinical audit was being carried out,

but confirmed it is in talks with the MHRA. 'We can confirm we are in

discussion with the MHRA regarding proposed updates of the product

characteristics of

Seroxat,' Glaxo's Martin Sutton said.

 

 

• SEROXAT is one of the biggest selling antidepressants in the world. It

treats depression, panic, obsessive compulsive disorder, post-traumatic stress

disorder, social anxiety disorder and general anxiety disorder. Last year

400,000

people were prescribed the treatment, also known as the 'anti-shyness pill',

in Britain alone.

 

 

 

 

 

 

 

 

Gettingwell- / Vitamins, Herbs, Aminos, etc.

 

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Or, go to our group site: Gettingwell

 

 

 

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