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Parliamentary questions
26 April 2017
E-002920-17
Question for written answer
to the Commission
Rule 130
Piernicola Pedicini (EFDD)

 Subject:  Administration of antidepressants to children and adolescents and pharmacovigilance in the EU
 Answer(s) 

In April 2007, a pharmacovigilance exercise was launched in Italy concerning attention deficit hyperactivity disorder (ADHD), through the establishment of a national register that enabled the use of methylphenidate (MPH) and atomoxetine (ATX) among growing children and adolescents to be monitored in order to ensure they are being used safely.

Thanks to the data collected by the ADHD National Register, it has been possible to estimate the risk profile of the psychotropics MPH and ATX for the treatment of children and adolescents, in addition to the prevalence of this disorder among the Italian population between the ages of 6 to 18, which has turned out to be slightly higher than 1% (considerably lower than estimated figures in other countries).

Can the Commission say:

Whether it is aware of these facts and whether it would not be appropriate to export the Italian model to other EU countries;
Whether it thinks that the extension of this register to other diseases, such as depression, might help to reduce the number of prescriptions and whether it knows of any similar experiences in other Member States;
Whether there are any activities under way to monitor the worrying increase in the use of antidepressants in children and teenagers, as already highlighted in a study published in March 2016 by the European Journal of Neuropsychopharmacology(1)?

(1) http://dx.doi.org/10.1016/j.euroneuro.2016.02.001

Original language of question: IT 
Last updated: 10 May 2017Legal notice