http://ablechild.org/alert.htm
Breaking News
Drugs for depressed children banned
Sarah Boseley, health editor
Wednesday December 10, 2003
The Guardian
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.
--------------------------------------------------------------------------
------
FDA Warns of Possible Drug-Suicide Link
WASHINGTON — Some anti-depressant drugs undergoing trials in children may be
associated with suicides, the Food and Drug Administration said Monday.
The agency said reports in the press and medical journals describe suicide
attempts and suicides in children receiving antidepressants. Many such reports
also have been submitted to the FDA.
While the data do not clearly establish an association between the use of the
drugs on trials and increased suicidal thoughts or actions by pediatric
patients, FDA said it also is impossible to rule out an association.
Determining if the drug was at fault is a problem, as suicide attempts also
occur in patients with depression who are untreated.
Nevertheless, the FDA said it is issuing a public health advisory to alert
physicians to reports of suicidal thinking and suicide attempts in clinical
studies of various anti-depressant drugs in pediatric patients.
Currently only Prozac is approved for use in major depressive disorder among
children, but physicians sometimes use other drugs approved for adults.
The FDA said it has completed a preliminary review of reports for eight
anti-depressant drugs — citalopram, fluoxetine, fluvoxamine, mirtazapine,
nefazodone, paroxetine, sertraline, and venlafaxine — in tests in children.
In addition to the advisory, the agency scheduled a meeting next February of
its Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee
of the Anti-Infective Drugs Advisory Committee to discuss the question.
Found on ajc.com
ajc.com is Copyright © 2003 The Atlanta Journal-Conststution
--------------------------------------------------------------------------
------
DCF Bans Second Antidepressant
September 18, 2003
By DAVE ALTIMARI, JACK DOLAN, And ANDREW JULIEN Courant Staff Writers
State officials will stop giving the antidepressant Effexor to children under
state care, citing concerns about a possible link to an increased suicide risk.
Effexor is the second antidepressant temporarily banned by the Department of
Children and Families in recent months. In July, Paxil was banned after the
U.S. Food and Drug Administration warned of a similar link.
Dr. Patricia Leebens, chairwoman of DCF's psychotropic medication advisory
committee, acknowledged that the bans limit the options for doctors treating
children with depression or anxiety disorders. But Leebens said she is worried
that too little is known about the drugs' ultimate effects on young patients.
"There is a concern that we will end up pulling all the medications that are
helpful to children off the market. But until we have more information, we
don't feel there is a choice," Leebens said. The bans are for six months, at
which time the decision will be reviewed.
Clinical trials done by the drugs' manufacturers at the request of the FDA
suggest that neither Paxil nor Effexor is particularly effective in treating
depression among teens and that both might lead to increased hostility and
thoughts of suicide.
But because the information from the trials is inconclusive, doctors treating
DCF patients can still get approval to use the drugs on a case by case basis.
Other antidepressants such as Prozac, Wellbutrin and Zoloft are still available
to doctors treating kids in DCF's care. DCF officials will not say how many of
their clients are being treated with Effexor or Paxil, but Leebens said both
are favored by child psychiatrists because they have fewer side effects, such
as nausea and dizziness, than other similar drugs.
Dr. Robert Sahl, medical director of child and adolescent psychiatry at
Hartford's Institute of Living, said recent warnings about Paxil and Effexor
have not created significant barriers to effectively treating his patients.
The Paxil restrictions announced by the FDA in June, for example, only apply to
children with major depressive disorder, one of several conditions the drug can
be used to treat.
"I don't think it's necessarily that limiting yet," Sahl said.
For years doctors have been free to treat patients of any age with Effexor and
other antidepressants, once the drugs were approved for general use. Federal
regulators did not ask pharmaceutical companies to test their pills on children
until the late 1990s, when it became apparent that they were regularly being
prescribed to patients under the age of 18.
The FDA's warning about Paxil was based on those trials. Two months later,
Wyeth Pharmaceuticals, based in New Jersey, took the step of informing doctors
that its own studies showed similar risks with Effexor.
In a two-page letter dated Aug. 22, Dr. Victoria Kusiak, Wyeth's vice president
for global medical affairs, warned that in recent pediatric trials Effexor was
not effective in treating depression or anxiety and that there were increased
reports of hostility and especially in Major Depressive Disorder,
suicide-related adverse events such as suicidal ideation and self-harm."
Wyeth spokesman Doug Petkus said that the August letter was meant to reinforce
the recommendation on Effexor's label, which states that the drug's "safety and
effectiveness" have not been established in pediatric patients. Effexor was
never specifically approved, or marketed, for use in patients under the age of
18, Petkus said.
DCF was the first public child-protection agency to ban Paxil after the FDA
recommended that it not be given to anyone under 18. Executives from
GlaxoSmithKline, the makers of Paxil, came to Connecticut last month to meet
with the DCF committee but did not convince the state officials to put Paxil
back on the list of approved drugs.
"The FDA is calling for all the data and this is only the beginning of this
issue. The committee wants to be cautious and wait for as much information as
possible," Lebens said.
Breaking News
Drugs for depressed children banned
Sarah Boseley, health editor
Wednesday December 10, 2003
The Guardian
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.
--------------------------------------------------------------------------
------
FDA Warns of Possible Drug-Suicide Link
WASHINGTON — Some anti-depressant drugs undergoing trials in children may be
associated with suicides, the Food and Drug Administration said Monday.
The agency said reports in the press and medical journals describe suicide
attempts and suicides in children receiving antidepressants. Many such reports
also have been submitted to the FDA.
While the data do not clearly establish an association between the use of the
drugs on trials and increased suicidal thoughts or actions by pediatric
patients, FDA said it also is impossible to rule out an association.
Determining if the drug was at fault is a problem, as suicide attempts also
occur in patients with depression who are untreated.
Nevertheless, the FDA said it is issuing a public health advisory to alert
physicians to reports of suicidal thinking and suicide attempts in clinical
studies of various anti-depressant drugs in pediatric patients.
Currently only Prozac is approved for use in major depressive disorder among
children, but physicians sometimes use other drugs approved for adults.
The FDA said it has completed a preliminary review of reports for eight
anti-depressant drugs — citalopram, fluoxetine, fluvoxamine, mirtazapine,
nefazodone, paroxetine, sertraline, and venlafaxine — in tests in children.
In addition to the advisory, the agency scheduled a meeting next February of
its Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee
of the Anti-Infective Drugs Advisory Committee to discuss the question.
Found on ajc.com
ajc.com is Copyright © 2003 The Atlanta Journal-Conststution
--------------------------------------------------------------------------
------
DCF Bans Second Antidepressant
September 18, 2003
By DAVE ALTIMARI, JACK DOLAN, And ANDREW JULIEN Courant Staff Writers
State officials will stop giving the antidepressant Effexor to children under
state care, citing concerns about a possible link to an increased suicide risk.
Effexor is the second antidepressant temporarily banned by the Department of
Children and Families in recent months. In July, Paxil was banned after the
U.S. Food and Drug Administration warned of a similar link.
Dr. Patricia Leebens, chairwoman of DCF's psychotropic medication advisory
committee, acknowledged that the bans limit the options for doctors treating
children with depression or anxiety disorders. But Leebens said she is worried
that too little is known about the drugs' ultimate effects on young patients.
"There is a concern that we will end up pulling all the medications that are
helpful to children off the market. But until we have more information, we
don't feel there is a choice," Leebens said. The bans are for six months, at
which time the decision will be reviewed.
Clinical trials done by the drugs' manufacturers at the request of the FDA
suggest that neither Paxil nor Effexor is particularly effective in treating
depression among teens and that both might lead to increased hostility and
thoughts of suicide.
But because the information from the trials is inconclusive, doctors treating
DCF patients can still get approval to use the drugs on a case by case basis.
Other antidepressants such as Prozac, Wellbutrin and Zoloft are still available
to doctors treating kids in DCF's care. DCF officials will not say how many of
their clients are being treated with Effexor or Paxil, but Leebens said both
are favored by child psychiatrists because they have fewer side effects, such
as nausea and dizziness, than other similar drugs.
Dr. Robert Sahl, medical director of child and adolescent psychiatry at
Hartford's Institute of Living, said recent warnings about Paxil and Effexor
have not created significant barriers to effectively treating his patients.
The Paxil restrictions announced by the FDA in June, for example, only apply to
children with major depressive disorder, one of several conditions the drug can
be used to treat.
"I don't think it's necessarily that limiting yet," Sahl said.
For years doctors have been free to treat patients of any age with Effexor and
other antidepressants, once the drugs were approved for general use. Federal
regulators did not ask pharmaceutical companies to test their pills on children
until the late 1990s, when it became apparent that they were regularly being
prescribed to patients under the age of 18.
The FDA's warning about Paxil was based on those trials. Two months later,
Wyeth Pharmaceuticals, based in New Jersey, took the step of informing doctors
that its own studies showed similar risks with Effexor.
In a two-page letter dated Aug. 22, Dr. Victoria Kusiak, Wyeth's vice president
for global medical affairs, warned that in recent pediatric trials Effexor was
not effective in treating depression or anxiety and that there were increased
reports of hostility and especially in Major Depressive Disorder,
suicide-related adverse events such as suicidal ideation and self-harm."
Wyeth spokesman Doug Petkus said that the August letter was meant to reinforce
the recommendation on Effexor's label, which states that the drug's "safety and
effectiveness" have not been established in pediatric patients. Effexor was
never specifically approved, or marketed, for use in patients under the age of
18, Petkus said.
DCF was the first public child-protection agency to ban Paxil after the FDA
recommended that it not be given to anyone under 18. Executives from
GlaxoSmithKline, the makers of Paxil, came to Connecticut last month to meet
with the DCF committee but did not convince the state officials to put Paxil
back on the list of approved drugs.
"The FDA is calling for all the data and this is only the beginning of this
issue. The committee wants to be cautious and wait for as much information as
possible," Leebens said.
)