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.
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
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.