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Adverse effects: children too

Studying the effects of drugs on children is a welcome move towards improved paediatric care. But that does not mean we should resort to drugs for every childhood illness.

The Caen regional pharmacovigilance centre has made a study of adverse drug effects observed in children aged 0 to 18.

The study examines 216 adverse effects reported over 6 years. 54% of the adverse effects were considered serious (effects on general health, neurological and skin reactions). 11% were due to medication errors or to off-licence use.

The European Regulation on medicines for paediatric use is going to be phased in over time. This Regulation is designed to promote the development and study of drugs for children. It should lead to improved knowledge of the effects of paediatric drugs. This will however come at the price of an increased number of trials involving children before the granting of a marketing authorisation, and at the price of financial incentives given to pharmaceutical companies. These rewards are linked neither to the therapeutic benefits for children, nor to the real cost of research and development.

The European Medicines Agency's Paediatric Committee and the various regulatory agencies have the means to ensure that priorities with regard to children’s real needs are respected, and to guarantee that the drugs approved offer a genuine therapeutic benefit. Prescrire urges the Committee to fulfil this role and warns that it will be watching.

©Prescrire November 2007

Source: "Effets indésirables des medicaments : les enfants aussi (suite)" Rev Prescrire 2007 ; 27 (289) : 833

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