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News2001January › Untested 'off-label' drugs often given to children › January 2001

Untested 'off-label' drugs often given to children

Many of the drugs given to children have never been proven to be safe or effective for children

Many of the drugs given to children have never been proven to be safe or effective for children.

In spite of this, the practice of giving sick children unlicenced drugs is widespread. The practice is part of a larger type of medical guesswork called 'off-label' prescribing, a blanket term for giving drugs by unconventional routes for an unlicenced indication or at an unlicenced dose (Lancet, 2000; 356: 1619).

The problem of off-label prescribing was highlighted in a recent trial monitoring the effects of the antiepileptic stiripentol, when added to the drugs valproate and clobazam, for a period of two months.

In this trial, adding stiripentol lowered the number of seizures in around 70 per cent of the cases, but all of the children in the drug treatment group had drug related adverse effects, including drowsiness and weight loss. The researchers found that the dose they had given the children was simply too high (Lancet, 2000; 356; 1638-42).

As children cannot usually be ethically included in randomised trials, little is known about which drugs and which doses are effective for them. The potential for serious error is real. An editorial accompanying the study noted that adverse reactions to off-label prescribing is twice as common as for licenced prescriptions.


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