PMID- 30169997
OWN - NLM
STAT- MEDLINE
DCOM- 20181019
LR  - 20190222
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 17
IP  - 10
DP  - 2018 Oct
TI  - Safety and tolerability profile of new antiepileptic drug treatment in children 
      with epilepsy.
PG  - 1015-1028
LID - 10.1080/14740338.2018.1518427 [doi]
AB  - INTRODUCTION: Treatment of pediatric epilepsy requires a careful evaluation of 
      the safety and tolerability profile of antiepileptic drugs (AEDs) to avoid or 
      minimize as much as possible adverse events (AEs) on various organs, 
      hematological parameters, and growth, pubertal, motor, cognitive and behavioral 
      development. AREAS COVERED: Treatment-emergent AEs (TEAEs) reported in the 
      literature 2000-2018 regarding second- and third-generation AEDs used in the 
      pediatric age, with exclusion of the neonatal period that exhibits specific 
      peculiarities, have been described on the basis of their frequency, 
      severity/tolerability, and particular association with a given AED. EXPERT 
      OPINION: Somnolence/sedation and behavioral changes, like irritability and 
      nervousness, are among the most commonly observed TEAEs associated with almost 
      all AEDs. Lamotrigine, Gabapentin, Oxcarbazepine, and Levetiracetam appear to be 
      the best-tolerated AEDs with a </=2% withdrawal rate, while Tiagabine and 
      Everolimus are discontinued in up to >20% of the patients because of intolerable 
      TEAEs. For some AEDs, literature data are scanty to draw a high-level evidence on 
      their safety and tolerability profile. The reasons are: insufficient population 
      size, short duration of treatments, or lack of controlled trials. A future goal 
      is that of identifying clearer, easier, and more homogeneous methodological 
      strategies to facilitate AED testing in pediatric populations.
FAU - Moavero, Romina
AU  - Moavero R
AUID- ORCID: 0000-0002-6200-060X
AD  - a Child Neurology and Psychiatry Unit, Systems Medicine Department , Tor Vergata 
      University of Rome , Rome , Italy.
AD  - b Child Neurology Unit, Neuroscience and Neurorehabilitation Department , 
      "Bambino Gesu", Children's Hospital, IRCCS , Rome , Italy.
FAU - Pisani, Laura Rosa
AU  - Pisani LR
AD  - c Neurology Unit , Cutroni Zodda Hospital , Barcelona (ME) , Italy.
FAU - Pisani, Francesco
AU  - Pisani F
AD  - d Department of Clinical and Experimental Medicine , University of Messina , 
      Messina , Italy.
FAU - Curatolo, Paolo
AU  - Curatolo P
AD  - a Child Neurology and Psychiatry Unit, Systems Medicine Department , Tor Vergata 
      University of Rome , Rome , Italy.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20180917
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Anticonvulsants)
SB  - IM
MH  - Age Factors
MH  - Anticonvulsants/administration & dosage/*adverse effects
MH  - Child
MH  - Child Behavior/drug effects
MH  - Epilepsy/*drug therapy
MH  - Humans
MH  - Sleep Stages/drug effects
OTO - NOTNLM
OT  - New antiepileptic drugs
OT  - adverse events
OT  - behavior
OT  - cognition
OT  - drug safety
OT  - drug tolerability
OT  - pediatric epilepsy
EDAT- 2018/09/01 06:00
MHDA- 2018/10/20 06:00
CRDT- 2018/09/01 06:00
PHST- 2018/09/01 06:00 [pubmed]
PHST- 2018/10/20 06:00 [medline]
PHST- 2018/09/01 06:00 [entrez]
AID - 10.1080/14740338.2018.1518427 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2018 Oct;17(10):1015-1028. doi: 
      10.1080/14740338.2018.1518427. Epub 2018 Sep 17.