[SSRI-Research] Guardian Reports: MHRA to Issue New SSRI Restrictions

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Tue, 15 Jun 2004 03:08:03 -0000

[sSRI-Research] Guardian Reports: MHRA to Issue New SSRI Restrictions

 

The Guardian reports that the British Committee on safety and

Medicines, which was first to issue warnings about the potential

suicidal risk for children prescribed an antidepressant of the SSRI

class, are now about to issue similar warnings for use in adults:

 

" The Guardian understands that it has found a similar picture and

that the drug regulatory body, the Medicines and Healthcare Products

Regulatory Agency (MHRA) is likely to impose restrictions on the use

of some of them. "

 

However, in what may be a demonstration of the capricious nature of

the drug approval process, the Guardian reports that the MHRA has

asked Eli Lilly to submit Prozac (fluoxetine) data for approval in

children.

 

When those who conduct the trials and those who review them are

financially dependent (directly or indirectly) upon the drug

industry, even evidence of drug-induced suicidal behavior, growth

reduction, mania, and abnormal heart beats--in those who take the

rugs--tend to be swept under the carpet.

 

 

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

 

 

http://society.guardian.co.uk/mentalhealth/story/0,8150,1238132,00.htm

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UK - Safety alert on adult use of antidepressants Sarah Boseley,

health editor Monday June 14, 2004 The Guardian

 

The modern antidepressant drugs which were thought to be a miracle

cure for 20th century misery only 10 years ago are expected to suffer

a second big blow this year when the UK authorities will warn that

some of them can cause adults to become suicidal.

 

An expert working group of the government's Committee on the Safety

of Medicine (CSM) has already warned that all but one of the SSRIs

(selective serotonin reuptake inhibitors), including the best-selling

Seroxat, should not be given to children. It found that there were

risks of children becoming suicidal, aggressive and suffering mood

swings, and the drugs were anyway not very effective.

 

Now the committee is close to completing its review of the safety and

efficacy of the SSRIs in adults. The Guardian understands that it has

found a similar picture and that the drug regulatory body, the

Medicines and Healthcare Products Regulatory Agency (MHRA) is likely

to impose restrictions on the use of some of them.

 

The decision will lead to further confusion and uncertainty among

doctors treating depression. Child psychiatrists and GPs have shown

conflicting reactions to the SSRI ban - some of them continuing to

use the drugs, while others hold off. Guidelines from the National

Institute for Clinical Excellence (Nice) on treating depression in

adults were due to be published this month, but have been postponed

pending the MHRA announcement. Guidelines on treating children are

not due until next year.

 

" With our colleagues it is very difficult, " said Sue Bailey, chair of

the child and adolescent faculty of the Royal College of

Psychiatrists. " They don't know whether they can or can't, should or

shouldn't prescribe. "

 

Two to 6% of children suffer from depression, and suicide is the

third leading cause of death in 10-to-19-year-olds, says Professor

Bailey. An estimated 40,000 children were on SSRIs last year.

 

The college has asked the expert group to give " plain English " advice

as to what doctors should do, but they have been told they must wait

until the MHRA has met to discuss the issues with the European drug

regulators. It is well-known that the authorities in some parts of

Europe would like the MHRA to tone down the SSRI ban, but Professor

Bailey says she finds it hard to see how the MHRA can recant. " It is

hard to row back on the data they have shown us, " she said.

 

A conference on the issues around ensuring medicines are safe for

children is taking place today, with contributions from Lord Warner,

the health minister responsible, and Sir Alasdair Breckenridge, chair

of the MHRA.

 

Yet the biggest problem in children's medication today, the SSRIs, is

not on the agenda. In a presentation next month, Prof Bailey will

call for government and other involved bodies to ensure children

have " the same rights to rigorously conducted research programmes " as

adults. She points out that the studies of depressed children so far

involve some as young as three, in whom depression has to be very

carefully diagnosed, using specially trained researchers.

 

One SSRI has not been banned for use in children - Prozac, which has

a licence to treat children's depression in the United States.

Yesterday the manufacturer, Eli Lilly, told the Guardian it had been

asked by the MHRA to apply for a licence to treat children with

depression in the UK and Europe.

 

Richard Brook, chief executive of the mental health charity Mind, who

resigned from the expert group on SSRIs because of what he claimed

was a lack of openness and transparency, said he was appalled that

the MHRA which polices the drug companies should approach one of them

to suggest it applies for a licence.

 

" This raises real issues about their impartiality, " he said. " They

are saying they want an SSRI to be given to children. It is not their

job to decide such a thing. If they are going to do deals with the

drug companies, where does it stop? This is a fundamental breach that

the minister must investigate. "

 

Vera Sharaz, from the Alliance for Human Research Protection in the

United States, says it is astonishing that Prozac ever got a licence

there for use in children, adding that documents from the Food and

Drug Administration

(FDA) which licensed it show that the first of two studies done, in

1997, failed to reach the target Eli Lilly had set for benefiting

children and the second, in 2002, produced serious side-effects,

including growth retardation and heart problems.

 

" Given the concern about evidence of a suicide link to Prozac and the

other antidepressants, it is an affront to the public that the MHRA

would even consider approving Prozac for children, " she said. Eli

Lilly in fact changed the label on the drug in the UK last December

to state: not recommended for children.

 

 

 

 

 

 

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