Pointless Prescriptions - an old phenomena

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Tough curbs on Prozac prescribed for children ·

Antidepressant only to be used with counselling· Drug

manufacturer must continue to monitor safety Monday

June 12, 2006 Prozac is to be licensed for treating

children over eight with depression, but regulators

have imposed an unprecedented restriction on its use,

ordering that it may not be prescribed unless talking

therapies have failed, and even then a course of the

drug must be accompanied by counselling.The conditions

imposed by the European licensing agency (EMEA) are

likely to result in Prozac being used less to treat

children. While neither Prozac nor any of the other

antidepressants of its class had a licence, doctors

were free to prescribe them as they liked.Because of

shortages of therapists and because they seemed a

quick and easy fix, the prescribing of Prozac and

other drugs known as SSRIs (selective serotonin

reuptake inhibitors) to adults and children soared.

The annual number of prescriptions to those under 18

leapt from 13,227 in 1995 to 27,658 in 2003.While

doctors can still theoretically prescribe " off label " ,

they are unlikely to flout the terms of the licence,

which will be laid down in the Summary of Product

Characteristics and written in the prescribing bible,

the British National Formulary. " Prozac should only be

used together with psychological therapy in patients

non-responding to such therapy alone after four to six

sessions, " said the EMEA in its recommendation to the

European commission, which will formally grant the

licence. If the child does not get better in nine

weeks, the drug treatment should be reconsidered, it

says.The move is unprecedented, according to Tim

Kendall, joint director of the National Collaborating

Centre for Mental Health, which formulated the NHS

guidelines on the treatment of depression in children.

" This is the first time to my knowledge that a drug

has been given a licence which includes a period of

psychological treatment before and during the drug

treatment, " he said.Eli Lilly, manufacturer of Prozac,

was specifically asked to apply for a licence by the

drug regulator, the Medicines and Healthcare Products

Regulatory Authority (MHRA). Prozac is the only

antidepressant of the SSRI class the MHRA exempted

from its general ban on use in children. Analysis of

trial data has shown that the risk children will

become suicidal on other SSRIs is greater than the

benefit they get from taking the drugs.With a licence

for use on children, Prozac will also be subject to

post-licensing surveillance by the MHRA, which will

look for reports of troubling side-effects. " I think

the MHRA will not take their eye off the ball now, "

said Dr Kendall.Eli Lilly has also been instructed by

the EMEA to " carry out additional studies to ensure

that the safety profile of Prozac remains acceptable " .

The agency also wants further investigation of

findings in the early animal safety studies on " sexual

development, emotional behaviour and testicular

toxicity " .