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4CPS-179 Attention-deficit/hyperactivity-disorder in adulthood: conflict between clinical needs and prescription status
  1. L Gambitta1,
  2. E Magni1,
  3. E Galfrascoli1,
  4. G Migliarese2,
  5. G Cerveri2,
  6. G Muserra1
  1. 1ASST Fatebenefratelli-Sacco, Hospital Pharmacy Unit, Milan, Italy
  2. 2ASST Fatebenefratelli-Sacco, C. P. S. Settembrini, Milan, Italy


Background ADHD is a clinical condition that can break out in childhood and can persist until adulthood. It has been demonstrated that ADHD in adulthood affects quality of life, in particular social and professional relationships. Although international guidelines indicate methylphenidate as a first-line treatment for ADHD in adulthood, in Italy it can be prescribed only for adults whose ADHD has been diagnosed before 18 years of age; it is not payed back for ADHD newly diagnosed in adults. As regards atomoxetine, it is authorised and payed back, but is indicated as second-line treatment (NICE). Our Psychiatric Department is involved in adult ADHD treatment and closely collaborated with the Pharmacy Unit to verify the latest available treatments.

Purpose The aim of this article is to compare methylphenidate and atomoxetine safety profiles, analysing pharmacovigilance reporting, in order to evaluate if it is justified to not use methylphenidate for newly diagnosed ADHD in adulthood.

Material and methods We evaluated available treatments by comparing safety profiles of methylphenidate and atomoxetine. We retrospectively (from 2007 to 2016) analysed the adverse events taken from the National Pharmacovigilance Network. The adverse events were related to atomoxetine, authorised for ADHD in adults (on-label regimen) and methylphenidate, not authorised in Italy for this indication. Adverse events were classified by gravity.

Results The pharmacovigilance national system reported 254 adverse events: 116 for atomoxetine (15 in adult patients) and 138 for methylphenidate (10 in adults). The 26% (30/116) of events correlated to atomoxetine were classified as serious, and five of these represent cases of attempted suicide. Regarding methylphenidate, the 12% (16/138) of adverse events were classified as serious and of these only one was dangerous for the patient (syncope). There was a difference of 14% between the two drugs.

Conclusion Adult patients newly diagnosed with ADHD could not be treated with methylphenidate, although international guidelines indicate it as the best therapeutic choice. Clinicians are obliged to prescribe methylphenidate as an off-label regimen, because of therapeutic indications. Analysing pharmacovigilance reporting it can be assessed that methylphenidate has a better safety profile compared to atomoxetine, in particular for serious adverse events.

Reference and/or Acknowledgements 1. NICE guidelines

No conflict of interest

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