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Medicines for paediatric use: meeting real needs

One of many problems: an analgesic for children was approved on the basis of an inadequate clinical evaluation.

The European Commission is preparing a draft EU regulation on paediatric drugs. The aim is apparently to offer manufacturers financial incentives to induce them to develop more paediatric drugs. An admirable aim, as long as there is a genuine need, and the clinical evaluation is rigorous.

The Medicines in Europe Forum has expressed reservations on the draft regulation and made some proposals to ensure that it better corresponds to actual needs (see the website www.prescrire.org).

Among many problems is the example of a paediatric drug whose clinical evaluation illustrates the very opposite of good practice. To relieve children suffering from acute or chronic ailments and suffering intense pain, a level 2 analgesic like tramadol could be helpful. However, tramadol has not been compared to the standard level 2 analgesic, codeine, but to paracetamol (underdosed), and to diclofenac (using a questionable methodology), which are level 1 analgesics, and the number of children in the trial was very low.

In short, we do not have much concrete information on the effect of this analgesic on children. And yet a marketing authorisation was granted for children over the age of three.

Drug regulatory agencies should be more stringent in their demands concerning the clinical evaluation of paediatric drugs. And the industry should stop considering children as a new niche market.

©Prescrire February 2005

Source: "Contre-exemple" Rev Prescrire 2005 ; 25 (258) : 88.

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