Fwd: [drugawareness] UK BANS ZOLOFT, CELEXA, LEXAPRO & LUVOX FOR UNDER 18's

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drugawareness

atracyphd2

Wed, 10 Dec 2003 12:37:41 EST

[drugawareness] UK BANS ZOLOFT, CELEXA, LEXAPRO & LUVOX FOR UNDER 18's

 

 

 

Wonderful news once again coming out of the UK! What debt of gratitude we owe

to those there who have worked so hard to bring this information out to the

public and make positive changes!

 

Although the MHRA (which is the UK version of our FDA) has banned Zoloft,

Celexa, Lexapro and Luvox for anyone under the age of 18, the exception is

Prozac. This is probably because our own FDA approved this drug in children last

January. Yet the agency did go on to state that the MHRA warns that, at best,

Prozac helps only one child of 10. Clearly when these drugs all work the same

way

there are just as many serious problems with Prozac in children as there are

in the use of its many clones which have now been banned.

 

Note that the article ends with this statement: " The SSRI review group, which

has advised the Committee on the Safety of Medicines of the agency to ban the

drugs from use in children, will now look at the safety and efficacy of the

drugs in adults. "

 

So clearly the MHRA is not finished with their investigation but has only

just begun!

 

For those of you who are interested, there will be a radio show this evening

on the case of a 12 year old boy who shot and killed his grandparents and then

burned their house down. He had taken Paxil and then was switched to Zoloft.

He had taken the drugs for about two months when the tragedy happened. The

show will be with radio host Jeff Rense at either 7:30 PM or 8:00 PM Pacific

Time

and can be heard live on line at www.rense.com. I will be on the show with

the boy's father, Lisa VanSyckel our NJ director and Jason Cato who is covering

the story for the local newspaper.

 

Dr. Ann Blake Tracy,

Executive Director, International Coalition For Drug Awareness

& author of Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& tape on safe withdrawal " Help! I Can't Get Off My Antidepressant! "

 

Order Number: 1-800-280-0730

Website: www.drugawareness.org

 

 

http://www.guardian.co.uk/uk_news/story/0,3604,1103563,00.html Drugs for

depressed children banned

 

Sarah Boseley, health editor

Wednesday December 10, 2003

<A HREF= " http://www.guardian.co.uk/ " >The Guardian</A>

 

Modern antidepressant drugs which have made billions for the pharmaceutical

industry will be banned from use in children today because of evidence,

suppressed for years, that they can cause young patients to become suicidal.

 

The Medicines and Healthcare Products Regulatory Agency (MHRA) told doctors

last night not to prescribe all but one of the antidepressants known as

selective serotonin reuptake inhibitors (SSRIs).

 

The exception is Prozac, which is licensed for use in depressed children in

the US. But the MHRA will warn that, at best, it helps only one child in 10.

 

The decision has big implications for drug regulation.

 

The agency - which is the government's watchdog body on drug safety - has

reached this point only after intense pressure from patients and campaigners.

 

They were concerned about patients - at first mainly adults - who appeared to

have become suicidal on the drugs, and others who had got hooked and suffered

distressing symptoms when they tried to stop taking them.

 

Public unease about these potential side-effects prompted the agency to

investigate last year. It has looked at the details of clinical trials of

depressed

children that were in the hands of the drug companies in the late 1990s.

These studiesrevealed the problem of suicidal behaviour in children, but the

companies did not draw it to the attention of the regulators in the US or the

UK.

 

It has become clear from the investigation that the regulators generally see

only a summary of the data resulting from trials. It is prepared for them by

the drug company only when it is seeking a licence.

 

The agency became aware of a problem with Seroxat in children this year only

when the manufacturer, GlaxoSmithKline, submitted data from trials which

finished in 1996.

 

Pressure for a change in the regulatory system will inevitably grow. Two of

the SSRI class of drugs have already been banned - or, technically,

contra-indicated in children - by the agency.

 

The first, in June, was Seroxat, which goes by the generic name paroxetine;

the second, in September, was Efexor (venlafaxine); joining them now will be

Lustral (sertraline), Cipramil (citalopram), Cipralex (escitalopram) and Faverin

(fluvoxamine).

 

Trials on children have not been carried out in all the drugs, but the

completed studies show a worrying increase in suicidal behaviour among those on

SSRIs compared with those given a placebo (sugar pill).

 

None of the drugs has a licence for use in children with depression in the

UK, but GPs have prescribed more and more SSRIs for children.

 

It is estimated that as many as 50,000 children on antidepressants in

Britain.

 

The agency will warn that patients should not stop their medication suddenly

to avoid withdrawal symptoms.

 

The ban will cause problems for doctors because insufficient counsellors and

psychotherapists are available to offer the alternative treatment of therapy,

and the bill to the NHS for such treatment would be much higher than the cost

of the drug prescriptions.

 

Drug companies began clinical trials on the safety and efficacy of the SSRIs

in children only after prompting by the US food and drug administration in the

early 90s.

 

David Healy, the director of the North Wales department of psychological

medicine, said: " It was standard practice for the FDA approving drugs like

Seroxat

(Paxil in the US) for adults in 1991 to write to the company and say this

drug will also be used in children - it would be helpful if you could run trials

in children so we can see what the safety profile is. "

 

But trials that did not produce favourable results were neither published nor

sent to the FDA or the MHRA.

 

The first major Seroxat trial in children was finished by 1996, but the

results were not published until 2001. Data was also gathered in 1996 after a

trial

of Lustral, manufactured by Pfizer, showing that 9% of depressed children on

the drug became suicidal.

 

Dr Healy, whose own researches led to the establishment of the SSRI review,

said yesterday: " They should have known by 1996 that there was a problem. GSK

and Pfizer were asked to do this by the regulators so that we knew what the

safety issues were. "

 

The drug companies dispute that a problem exists. Only a tiny minority of

children taking the drug become suicidal and their depression could be the real

cause, they claim. GSK says several trials, not just one, were needed to

establish whether its drug caused problems.

 

The SSRI review group, which has advised the Committee on the Safety of

Medicines of the agency to ban the drugs from use in children, will now look at

the

safety and efficacy of the drugs in adults.