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Table 2 Suggested monitoring pattern and AEs management strategiesa

From: Update on the safety of second generation antipsychotics in youths: a call for collaboration among paediatricians and child psychiatrists

Time What to do Results Possible strategies
I Step General and neurological examination (weight, waist circumference, blood pressure…) Normal Plan a careful and tailored monitoring program/psychoeducation on drug side effects/healthy lifestyle, including diet and, when possible, exercise
 Baseline
Abnormal
Careful anamnestic interview about personal and familiar history of: Dyslipidemia, DM2, Obesity, Thyroid dysfunction, Arrythmogenic risk (sudden death, syncope, Prolonged QTc, Brugada syndrome) Negative History Regular monitoring
Positive History Plan a careful and close monitoring program/psychoeducation on drug side effects/healthy lifestyle/ECG (see below)
Blood examination for haemachrome, liver function, glucose, insulin and lipid profile, (thyroid function and PRL if possible) Normal Regular monitoring/healthy lifestyle
Glucose, transaminases, insulin and/or lipids significantly increased Careful and close monitoring/psychoeducation/chose a SGA with lower metabolic impact
ECG (in case of Ziprasidone or positive personal or familiar history) Normal ECG and QTc<450 msec Monitoring
QTc>450 msec or other arrythmogenic signs Discuss with paediatric cardiologist about the cardiac safety and the risk- benefit ratio in starting a SGA/if possible chose another drug class or a SGA with lower impact on QTc
II Step Weight and waist circumference monitoring Weight gain <7 % of baseline weight Regular monitoring/healthy lifestyle
 1 month control
Weight gain >7 % of baseline weight Careful and close monitoring/Healthy lifestyle/Psychoeducation/if possible switch to another SGA
Blood examination for haemachrome, liver function, glucose, insulin and lipid profile Normal Regular monitoring/healthy lifestyle
Glucose, transaminases, insulin and/or lipids significantly increased Careful and close monitoring/Healthy lifestyle interventions/Psychoeducation/if possible switch to another SGA
PRL related symptoms (galactorrhea, increased breasts volume, sexual dysfunction…) monitoring - symptoms Regular monitoring
+ symptoms Blood prolactin determination/if possible lower the SGA dose/if possible switch to another SGA/if possible add Aripiprazole/discuss with paediatric endocrinologist the possible add on of a prolactin-lowering drug (cabergoline or bromocriptine)
EPS and other neurological symptoms monitoring - EPS Regular monitoring
+ EPS If possible lower dose/if possible add on anticholinergics or benzodiazepines
NMS symptoms Hospitalization
ECG (in case of Ziprasidone or positive personal of family history) Normal ECG and QTc<450 msec Regular monitoring
QTc>450 msec or increase from 60 msec from baseline or other arrythmogenic signs Discuss with paediatric cardiologist about the cardiac safety and the risk- benefit ratio in continuing a SGA/possible SGA discontinuation
III Step Weight and waist circumference monitoring Weight gain <7 % of baseline weight Regular monitoring/healthy lifestyle
 3-, 6- month and periodic (every 6 months)
Weight gain still increasing Careful and close monitoring/Healthy lifestyle/Psychoeducation/if possible switch to another SGA
Blood examination for haemachrome, liver function, glucose, insulin and lipid profile Normal Regular monitoring/healthy lifestyle
Glucose, transaminases, insulin and/or lipids significant increased Careful and close monitoring/Healthy lifestyle interventions/Psychoeducation/if possible switch to another SGA
PRL blood determination Normal PRL Regular monitoring
PRL↑- associated symptoms Careful and close monitoring/if possible lower SGA dose/if possible switch to another SGA/if possible add Aripiprazole/discuss with pediatric endocrinolgist to add on cabergoline or bromocriptine
PRL↑ + associated symptoms
EPS and other neurological symptoms monitoring - EPS Regular monitoring
+ EPS If possible lower dose/if possible add on anticholinergic or benzodiazepines
NMS symptoms Hospitalization
ECG (if possible and feasible; mandatory in case of Ziprasidone or positive personal of family history) Normal ECG and QTc<450 msec Regular monitoring
QTc>450 msec or increase from 60 msec from baseline or other arrythmogenic signs Discuss with paediatric cardiologist about the cardiac safety and the risk benefit ratio of SGA continuation/possible SGA discontinuation
  1. Legend: AE adverse effects, DM2 Diabetes Mellitus type 2, ECG electrocardiogram, NMS neuroleptic malignant syndrome, PRL prolactin, EPS extrapyramidal symptoms
  2. aThe table summarizes findings from the present review (and is inspired by previously published guidelines [17, 18]); it is limited to the AEs reviewed in the present review; it would represent a guide for clinicians without replacing their clinical judgement