Pill warning for young Americans

Depression affects up to 5% of US youths, Prozac's makers say

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.

We continue to believe... these drugs provide significant benefits for paediatric patients when used appropriately Dr Lester Crawford FDA acting commissioner

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 appropriately".

'Dangerous' message

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

"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.