PFPC Daily, April 26, 2005

Britain set for clash with Europe over ban on Prozac for under-18s

The Independent, 26 April 2005

By Jeremy Laurance, Health Editor

Europe's drugs watchdog has banned Prozac and other modern
antidepressants for under-18s because of safety fears, putting it on
a collision course with Britain's drugs regulator.

Antidepressants increase suicidal thoughts and suicide attempts among
children and adolescents, and should not be used to treat depression,
the scientific panel of the European Medicines Agency (Emea) said.
Including Prozac in the ban clashes with the stance taken by Britain's
drugs regulator 16 months ago. Prozac is the only antidepressant that
doctors can prescribe to children in Britain, following a safety
review in 2003.

The drug was singled out by the UK Medicines and Healthcare Products
Regulatory Authority (MHRA) as the only one of the modern generation
of antidepressants that was effective and safe for children. All
others were banned for children in December 2003.

Prozac is not licensed for treating depression in the UK but doctors
are free to prescribe it provided they take personal responsibility
for doing so.

It is licensed for treating children with depression in the US, but
regulators there ordered last September that packs should carry the
severest "black-box" warning after concluding that it could increase
suicide risk. Until the UK ban was announced in December 2003, it is
estimated up to 50,000 children were being treated with
antidepressants in the UK. The review of the drugs by the MHRA and
Emea was prompted by reports of suicides linked to Seroxat, the
world's biggest-selling antidepressant, made by GlaxoSmithKline. Its
use among children was banned in June 2003 after new information about
its safety became available to the MHRA.

Emea said its review of all the drugs had revealed that suicide
attempts and suicidal thoughts, aggression and anger were more common
in clinical trials of children taking antidepress-ants, including
Prozac, than in those taking a placebo. "The agency is therefore
recommending the inclusion of strong warnings across the whole of the
European Union to doctors and parents about these risks. Doctors and
parents will also be advised that these products should not be used in
children and adolescents except in their approved indications."
Approved indications include obsessive-compulsive disorder and
attention deficit/ hyperactivity disorder, but do not include
depression.

The recommendation of the agency's scientific panel must be ratified
by the full Emea within three months, normally a rubber-stamping
exercise. But a spokes-woman for the MHRA said that it would seek to
change the recommendation. She said: "There is still time to influence
it. We back what Emea's scientific panel is saying but the key
difference is that Prozac is the one drug for which there is
clinical-trial evidence that it is effective. The profession know they
are going to have to prescribe something and it is important they know
what the dangers are and the best way of prescribing it. We think it
is safe to use so long as it is monitored carefully."

The MHRA's review of modern antidepressant drugs in treating adults
concluded in December last year that they had been over-prescribed to
hundreds of thousands with mild depression in whom the risk of
side-effects outweighed the benefits.

http://news.independent.co.uk/uk/health_medical/story.jsp?story=633067