Fwd: [drugawareness] IRELAND JOINS ENGLAND - NO PAXIL UNDER AGE 18

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atracyphd2

Wed, 11 Jun 2003 13:07:08 EDT

[drugawareness] IRELAND JOINS ENGLAND - NO PAXIL UNDER AGE 18

 

 

 

 

" Authorities in Ireland immediately followed the British lead, while the U.S.

Food and Drug Administration is evaluating the latest data and Europe's CPMP

expert committee on medicines has also been alerted.

 

" GSK insisted its drug was safe and effective but Alastair Benbow, head of

European psychiatry, said the group would work to implement the changes as soon

as possible. "

 

Ireland has followed the British lead in warning against the use of Paxil in

those under age 18 while the US FDA continues to evaluate data. How wonderful

to see the authorities in Ireland not hesitate to follow with this warning to

young people. I would hope that other countries would continue to join in

this critical warning against such serious dangers.

 

What bothers me the most is the statement by Dr. Alastair Benbow, head of

European psychiatry when he said that " the group would work to implement the

changes as soon as possible. "

 

What concerns me about that statement is that in their rush to implement

changes is discontinuing these young patients from Paxil abruptly or too

rapidly.

Without taking about half the amount of time the patient has been on the drug

to wean them off VERY SLOWLY you can often end up with terrible withdrawal

effects that can take years to overcome and can lead to withdrawal-induced

bipolar disorder or psychosis or suicidal tendencies.

 

This is what the US FDA did with the diet drugs, Fen Phen and Redux, which

are so similar in action to the SSRIs. The abrupt withdrawal caused many to go

psychotic or manic or became suicidal. Many ended up on the SSRI

antidepressants because of the withdrawal effects. I fear that pulling these

children off

Paxil too abruptly would make a whole new market for the newer anti-psychotics.

 

So, in these decisions I would hope they consider the time necessary to

withdraw properly from these drugs. Better yet, they could use my tape, Help! I

Can't Get Off My Antidepressant " (800-280-0730) to learn the safest way patients

have found to get off these drugs without experiencing the terrible withdrawal

- such a horrible experience that Glaxo is facing several lawsuits over this

withdrawal already. It is also critical to know how to come off correctly in

order to avoid the long term after effects that can lead the patients to use

other more potent drugs they would not need if they were withdrawn properly to

begin with.

 

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition For Drug Awareness

www.drugawareness.org & author of Prozac: Panacea

or Pandora? - Our Serotonin Nightmare (800-280-0730)

_

 

 

http://story.news./news?tmpl=story &

u=/nm/20030610/sc_nm/health_glaxo_seroxat_dc

 

UK Says Children Should Not Take Glaxo's Seroxat [Paxil]

 

Tue Jun 10,11:08 AM ET

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By Ben Hirschler and Richard Woodman

 

LONDON (Reuters) - British drug regulators warned on Tuesday that

GlaxoSmithKline Plc's controversial top-selling antidepressant Seroxat should

not be used

to treat depression in people under 18.

 

The Medicines and Healthcare products Regulatory Authority (MHRA) said new

data received in the last two weeks showed an increase in the rate of self-harm

and potentially suicidal behaviors in this age group when Seroxat was

prescribed.

 

" It has become clear that the benefits of Seroxat in children for the

treatment of depressive illness do not outweigh these risks, " the MHRA said in a

statement.

 

Seroxat, known as Paxil in the United States, belongs to the same class of

SSRIs (Selective Serotonin Reuptake Inhibitors) as Eli Lilly & Co's Prozac. It

generated global sales of 2.06 billion pounds ($3.40 billion) in 2002, of which

some 100 pounds million was sold in Britain.

 

But the medicine -- one of the world's best-selling pharmaceuticals -- has

been the subject of increased public concern due to reports of adverse

reactions, prompting Britain to set up an expert panel to investigate.

 

Although only officially approved for adults, doctors have had discretion to

prescribe Seroxat to young people on a so-called " off-label " basis. A total of

four million prescriptions were written for Seroxat in Britain last year,

with around 8,000 patients under 18 receiving treatment.

 

New data from various clinical trials showed episodes of self-harm and

potentially suicidal behavior were between 1.5 and 3.2 times higher in under-18s

taking Seroxat than in those receiving a placebo, or dummy, pill, the MHRA said.

 

Professor Alasdair Breckenridge, chairman of the MHRA, said there would be an

urgent examination of what implications, if any, the new findings would have

for the use of other SSRIs and Seroxat in adults.

 

FDA (<A

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Authorities in Ireland immediately followed the British lead, while the U.S.

Food and Drug Administration is evaluating the latest data and Europe's CPMP

expert committee on medicines has also been alerted.

 

Company spokeswoman Mary Anne Rhyne said, however, GSK was still pursuing an

application to market Paxil in the U.S. for children with obsessive compulsive

disorder. Paxil is already licensed for adults with the condition. As in

Britain, it is also used off-label for treating youngsters with depression.

 

Two years ago a Wyoming jury in the United States awarded $6.4 million to the

family of a patient taking the drug who murdered his wife, daughter and

granddaughter and then committed suicide in what the family said was a reaction

to

the drug.

 

And in March this year a British coroner asked for its withdrawal pending

more studies when a retired headteacher committed suicide after taking Seroxat

for a fortnight.

 

Britain's Royal College of Psychiatrists said it had been concerned for many

years about off-label prescribing of Seroxat and welcomed the curbs on use in

young people.

 

GSK insisted its drug was safe and effective but Alastair Benbow, head of

European psychiatry, said the group would work to implement the changes as soon

as possible.

 

June Raine, who supervises drugs already on the market, said the MHRA was

introducing a new system to evaluate how companies monitored risks associated

with their products and would consider including GSK in the process.

 

The new restrictions on Seroxat had been expected, after sources said on

Monday Britain was preparing to update safety guidelines, focusing on potential

problems among under-18s.

 

GSK shares slipped 0.6 percent to 12.54 pounds by 1505 GMT, behind the

European sector, up 0.2 percent.

 

Lehman Brothers analyst Matthew Weston said the financial impact was limited,

since under-18 use accounted for less than one percent of UK prescriptions.

In the U.S., pediatric use of Paxil represents a " low single digit " percentage

of total sales. ($1=.6064 Pound)