Industry supports 'black box'plan Financial Times UK

[Guest guest]

http://news.ft.com/cms/s/9464eed0-078d-11d9-9672-00000e2511c8.html

Industry supports 'black box'plan

By Bowe in New York

Published: September 16 2004 03:00 | Last updated: September 16 2004

03:00

Drugmakers reacted pos-itively to a US regulatory panel's

recommended warning that antidepressants increase risk of suicidal

tendencies in children, eager to put the contentious issue behind

for good.

A Food and Drug Administration advisory committee comprised of

outside medical experts on Tuesday said all antidepressants should

carry a " black box warning " - the severest label warning - about the

link between antidepressants and suicidal behaviour in minors. The

committee's conclusion is a recommendation to FDA regulators, who

often take such panels' advice.

The committee also concluded that research trials on nine

antidepressants showed on average that they were twice as likely to

prompt suicidal tendencies than children taking a sugar pill.

Its recommendation also provided some closure for drugmakers, which

have withstood withering criticism and scrutiny over this issue -

including how drugmakers handled trial data demonstrating adverse

effects on children.

GlaxoKline, which makes Paxil, said: " We are pleased to now

have that advice and be able to move forward with the FDA to develop

appropriate labelling and information for patients and physicians. "

More importantly, the FDA panel recommendation stopped short of UK

regulators' decision last year to warn that antidepressants, except

for Eli Lilly's Prozac, were unsuitable for children because of

these risks.

Although Prozac is the only antidepressant that is approved for use

by children, doctors are still allowed to prescribe drugs not

approved for such use in the patient's best interest.

Many, including FDA officials, are concerned that untreated

depression would expose children to increased suicide risk.

Wyeth, the manufacturer of antidepressant Effexor, said that

it " supports " the decision to " strengthen the product labels across

the antidepressant category regarding use in the paediatric

population " .

It added: " The committee's recommendation will ensure continued

access by physicians to these drugs for children suffering from

depression. "

According to Lehman Brothers and IMS, total prescriptions for

antidepressants climbed 6 per cent in June, 1 per cent in July and 5

per cent in August.

[Guest guest]

http://news.ft.com/cms/s/9464eed0-078d-11d9-9672-00000e2511c8.html

Industry supports 'black box'plan

By Bowe in New York

Published: September 16 2004 03:00 | Last updated: September 16 2004

03:00

Drugmakers reacted pos-itively to a US regulatory panel's

recommended warning that antidepressants increase risk of suicidal

tendencies in children, eager to put the contentious issue behind

for good.

A Food and Drug Administration advisory committee comprised of

outside medical experts on Tuesday said all antidepressants should

carry a " black box warning " - the severest label warning - about the

link between antidepressants and suicidal behaviour in minors. The

committee's conclusion is a recommendation to FDA regulators, who

often take such panels' advice.

The committee also concluded that research trials on nine

antidepressants showed on average that they were twice as likely to

prompt suicidal tendencies than children taking a sugar pill.

Its recommendation also provided some closure for drugmakers, which

have withstood withering criticism and scrutiny over this issue -

including how drugmakers handled trial data demonstrating adverse

effects on children.

GlaxoKline, which makes Paxil, said: " We are pleased to now

have that advice and be able to move forward with the FDA to develop

appropriate labelling and information for patients and physicians. "

More importantly, the FDA panel recommendation stopped short of UK

regulators' decision last year to warn that antidepressants, except

for Eli Lilly's Prozac, were unsuitable for children because of

these risks.

Although Prozac is the only antidepressant that is approved for use

by children, doctors are still allowed to prescribe drugs not

approved for such use in the patient's best interest.

Many, including FDA officials, are concerned that untreated

depression would expose children to increased suicide risk.

Wyeth, the manufacturer of antidepressant Effexor, said that

it " supports " the decision to " strengthen the product labels across

the antidepressant category regarding use in the paediatric

population " .

It added: " The committee's recommendation will ensure continued

access by physicians to these drugs for children suffering from

depression. "

According to Lehman Brothers and IMS, total prescriptions for

antidepressants climbed 6 per cent in June, 1 per cent in July and 5

per cent in August.

[Guest guest]

http://news.ft.com/cms/s/9464eed0-078d-11d9-9672-00000e2511c8.html

Industry supports 'black box'plan

By Bowe in New York

Published: September 16 2004 03:00 | Last updated: September 16 2004

03:00

Drugmakers reacted pos-itively to a US regulatory panel's

recommended warning that antidepressants increase risk of suicidal

tendencies in children, eager to put the contentious issue behind

for good.

A Food and Drug Administration advisory committee comprised of

outside medical experts on Tuesday said all antidepressants should

carry a " black box warning " - the severest label warning - about the

link between antidepressants and suicidal behaviour in minors. The

committee's conclusion is a recommendation to FDA regulators, who

often take such panels' advice.

The committee also concluded that research trials on nine

antidepressants showed on average that they were twice as likely to

prompt suicidal tendencies than children taking a sugar pill.

Its recommendation also provided some closure for drugmakers, which

have withstood withering criticism and scrutiny over this issue -

including how drugmakers handled trial data demonstrating adverse

effects on children.

GlaxoKline, which makes Paxil, said: " We are pleased to now

have that advice and be able to move forward with the FDA to develop

appropriate labelling and information for patients and physicians. "

More importantly, the FDA panel recommendation stopped short of UK

regulators' decision last year to warn that antidepressants, except

for Eli Lilly's Prozac, were unsuitable for children because of

these risks.

Although Prozac is the only antidepressant that is approved for use

by children, doctors are still allowed to prescribe drugs not

approved for such use in the patient's best interest.

Many, including FDA officials, are concerned that untreated

depression would expose children to increased suicide risk.

Wyeth, the manufacturer of antidepressant Effexor, said that

it " supports " the decision to " strengthen the product labels across

the antidepressant category regarding use in the paediatric

population " .

It added: " The committee's recommendation will ensure continued

access by physicians to these drugs for children suffering from

depression. "

According to Lehman Brothers and IMS, total prescriptions for

antidepressants climbed 6 per cent in June, 1 per cent in July and 5

per cent in August.

[Guest guest]

http://news.ft.com/cms/s/9464eed0-078d-11d9-9672-00000e2511c8.html

Industry supports 'black box'plan

By Bowe in New York

Published: September 16 2004 03:00 | Last updated: September 16 2004

03:00

Drugmakers reacted pos-itively to a US regulatory panel's

recommended warning that antidepressants increase risk of suicidal

tendencies in children, eager to put the contentious issue behind

for good.

A Food and Drug Administration advisory committee comprised of

outside medical experts on Tuesday said all antidepressants should

carry a " black box warning " - the severest label warning - about the

link between antidepressants and suicidal behaviour in minors. The

committee's conclusion is a recommendation to FDA regulators, who

often take such panels' advice.

The committee also concluded that research trials on nine

antidepressants showed on average that they were twice as likely to

prompt suicidal tendencies than children taking a sugar pill.

Its recommendation also provided some closure for drugmakers, which

have withstood withering criticism and scrutiny over this issue -

including how drugmakers handled trial data demonstrating adverse

effects on children.

GlaxoKline, which makes Paxil, said: " We are pleased to now

have that advice and be able to move forward with the FDA to develop

appropriate labelling and information for patients and physicians. "

More importantly, the FDA panel recommendation stopped short of UK

regulators' decision last year to warn that antidepressants, except

for Eli Lilly's Prozac, were unsuitable for children because of

these risks.

Although Prozac is the only antidepressant that is approved for use

by children, doctors are still allowed to prescribe drugs not

approved for such use in the patient's best interest.

Many, including FDA officials, are concerned that untreated

depression would expose children to increased suicide risk.

Wyeth, the manufacturer of antidepressant Effexor, said that

it " supports " the decision to " strengthen the product labels across

the antidepressant category regarding use in the paediatric

population " .

It added: " The committee's recommendation will ensure continued

access by physicians to these drugs for children suffering from

depression. "

According to Lehman Brothers and IMS, total prescriptions for

antidepressants climbed 6 per cent in June, 1 per cent in July and 5

per cent in August.