UK - Safety alert on adult use of antidepressants : Boseley, The Guardian

[Guest guest]

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

The Guardian

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

ml

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 , 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

. 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 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 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.

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.

[Guest guest]

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

The Guardian

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

ml

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 , 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

. 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 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 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.

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.

[Guest guest]

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

The Guardian

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

ml

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 , 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

. 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 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 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.

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.

[Guest guest]

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

The Guardian

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

ml

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 , 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

. 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 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 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.

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.