be prescribed for children as young as eight
by Mike George
can be prescribed for depressed children as young as eight –
but only if they are also having psychological therapy, the European
drugs regulator has ruled.
Up to now Prozac – known also as fluoxetine – has been
widely prescribed without a licence, or “off label”,
to under 18s in the UK.
But the European Medicines Agency has now licensed Prozac throughout
the European Union to children aged 8 years or older who have moderate
to severe depression.
However, the agency’s Committee For Medicinal Products For
Human Use (CHMP) concluded that while the benefits of using Prozac
for children outweighs its risks, the drug’s manufacturers,
Eli Lilly, should carry out further studies to ensure the safety
The CHMP also ruled that doctors should only prescribe Prozac for
children if they are also having psychological therapy, and only
if they have also not responded to such therapy after four to six
If Prozac shows no clinical benefit within nine weeks, then treatment
should be “reconsidered”, ruled the CHMP.
Doctors and parents should also carefully monitor children and adolescents
for suicidal behaviour, particularly at the beginning of Prozac
treatment, said the CHMP.
Prozac is the only antidepressant of the selective serotonin reuptake
inhibitor (SSRI) class which the UK drugs regulatory body, the Medicines
and Healthcare Products Regulatory Agency has exempted from a ban
on use in under 18s, due to increased suicide risk.
28, 2005: Do not prescribe anti-depressants to children with mild
depression, government urges - guideline states SSRI antidepressants
carry a risk of suicidal behaviour
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