The article “Off-label is not always off-evidence: authorising paediatric indications for old medicines” has been just published in The Lancet – Child & Adolescent Health!
Lucia Ruggieri from Fondazione Gianni Benzi, cooperated, as co-author, in this relevant work.
The manuscript deals with off-label use of paediatric medicines and particularly old medicines.
Approximately half of all paediatric medicine prescriptions in Europe are off-label. This means that they are administered for an unapproved indication or in an unapproved age group, dosage, or route of administration.
However, evidence supporting the efficacy and safety of these prescriptions is not adequate.
The current legislation mandates paediatric clinical trials for new medicines and for medicines still under patent protection.
By contrast, for financial and practical reasons, older medicines are unlikely to be investigated to the same extent.
Nevertheless, many children need to be treated with these old medicines! Considerable data are often available to support a paediatric indication, but these data are not included on medicine labels. In addition, authors highlight that the quality of these data and their level of evidence must be considered.
Discover more by reading the article here!