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[e-drug] Antidepressants in USA to carry warning for young

E-DRUG: Antidepressants in USA to carry warning for young 

The FDA has ordered manufacturers to display warnings of the risks of 
anti-depressants in young people.  However, this warning also applies to 
those drugs that have been approved for use in children.

Story from BBC NEWS:

Pill warning for young Americans

Antidepressants on sale in the United States will have to carry a stark new 
warning of their link to suicidal behaviour among young people.

America's Food and Drug Administration has ordered manufacturers to display 
a message that such drugs may increase the chance of suicidal thoughts.

The "black box" warning will also say if the drugs have been approved for 
use by children and teenagers.

But critics suggest such messages may actually exacerbate health problems.

The FDA said it was not seeking to prohibit the use of antidepressants but 
merely trying to strike a balance between the risk of suicidal behaviour 
and "clinical need".

"Antidepressants increase the risk of suicidal thinking and behaviour... in 
children and adolescents with major depressive disorder and other 
psychiatric disorders," the warning begins.

It appears inside a black box in bold letters - the strongest warning the 
US can put on prescription drugs - and is expected to start appearing in 
the next month or two.

The FDA's announcement follows a Congressional hearing in which the agency 
was criticised for being slow to recognise the link between antidepressants 
and suicidal thoughts in some children.

Independent survey

The FDA issued its order to manufacturers on the basis of the "latest and 
best science", Dr Lester Crawford, the FDA's acting commissioner, told 
reporters in Washington.

A survey had found that, on average, 2% to 3% of children taking 
antidepressants had increased suicidal thoughts.

The data was obtained by independent health experts working with New York's 
Columbia University and was based on data from 24 trials involving more 
than 4,400 patients taking antidepressants.

They found a greater risk during the first few months of treatment.

Parents whose children are on the drugs will now be advised to look out for 
warning signs, such as worsening depression, agitation and irritability.

Dr Crawford stressed that the FDA did continue to believe antidepressants 
provided "significant benefits for paediatric patients when used 

'Dangerous' message

However, the American Psychiatric Association said it feared the new 
warning might discourage antidepressant prescriptions for patients most in 

"This would put seriously ill patients at grave risk," a statement said.

Prozac is the only antidepressant found to be safe and effective for 
children. Its manufacturer, Eli Lilly and Co, also voiced concern.

A "black box warning on antidepressants may have a dangerous effect on 
appropriate prescribing for patients who urgently need proven treatment 
options", Prozac's producer said.

GlaxoSmithKline, another pill manufacturer, welcomed the new warnings.

"We agree with the FDA that providing additional information to everyone... 
is one of the most positive steps that can be taken to advance the 
diagnoses and treatment of adolescents with depression," said company 
spokeswoman Mary Anne Rhyne.

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