PMID- 24748641 OWN - NLM STAT- MEDLINE DCOM- 20141021 LR - 20151119 IS - 1468-2044 (Electronic) IS - 0003-9888 (Linking) VI - 99 IP - 9 DP - 2014 Sep TI - Safety of medicines used for ADHD in children: a review of published prospective clinical trials. PG - 866-72 LID - 10.1136/archdischild-2013-304170 [doi] AB - OBJECTIVE: To assess the long-term safety of drugs for attention deficit hyperactivity disorder (ADHD). METHODS: A bibliographic search was performed in the MEDLINE, EMBASE and PsycINFO databases for prospective studies evaluating the incidence of adverse events (AEs) in children and adolescents treated for ADHD. RESULTS: A total of six prospective studies that monitored drug safety during therapy for at least 12 weeks were retrieved. The drugs studied were atomoxetine (two studies, 802 patients), osmotic-controlled released oral methylphenidate formulation (two studies, 512 patients), extended release formulation of mixed amphetamine salts (one study, 568 patients) and transdermal methylphenidate (one study, 326 patients). Heterogeneity was found in the duration of follow-up (ranging between 1 and 4 years) and in the way data were reported. The rate of treatment-related AEs ranged from 58% to 78%, and the rate of discontinuation due to AEs ranged from 8% to 25% of the children. Decreased appetite, insomnia, headache and abdominal pain were the most common AEs observed. Most AEs and cases of discontinuation occurred during the first few months of treatment. CONCLUSIONS: Few studies evaluated the long-term safety of drugs for ADHD. Heterogeneity in follow-up duration and in data reporting made comparing different studies and drugs difficult. A systematic monitoring of long-term safety is needed. CI - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. FAU - Clavenna, Antonio AU - Clavenna A AD - Laboratory for Mother and Child Health, Department of Public Health, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy. FAU - Bonati, Maurizio AU - Bonati M AD - Laboratory for Mother and Child Health, Department of Public Health, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy. LA - eng PT - Journal Article PT - Review DEP - 20140419 PL - England TA - Arch Dis Child JT - Archives of disease in childhood JID - 0372434 RN - 0 (Amphetamines) RN - 0 (Central Nervous System Stimulants) RN - 0 (Propylamines) RN - 207ZZ9QZ49 (Methylphenidate) RN - 57WVB6I2W0 (Atomoxetine Hydrochloride) SB - IM MH - Adolescent MH - Amphetamines/adverse effects/therapeutic use MH - Atomoxetine Hydrochloride MH - Attention Deficit Disorder with Hyperactivity/*drug therapy MH - Central Nervous System Stimulants/administration & dosage/adverse effects/*therapeutic use MH - Child MH - Humans MH - Methylphenidate/adverse effects/therapeutic use MH - Propylamines/adverse effects/therapeutic use MH - Prospective Studies MH - Treatment Outcome OTO - NOTNLM OT - Child Psychiatry OT - Pharmacology EDAT- 2014/04/22 06:00 MHDA- 2014/10/22 06:00 CRDT- 2014/04/22 06:00 PHST- 2014/04/22 06:00 [entrez] PHST- 2014/04/22 06:00 [pubmed] PHST- 2014/10/22 06:00 [medline] AID - archdischild-2013-304170 [pii] AID - 10.1136/archdischild-2013-304170 [doi] PST - ppublish SO - Arch Dis Child. 2014 Sep;99(9):866-72. doi: 10.1136/archdischild-2013-304170. Epub 2014 Apr 19.