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Table 3 Suggested adverse event monitoring for selected medications used to treat labeled and unlabeled psychiatric indications in children and adolescents

From: Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring

Drug Class

Drug

Adverse Events

Comment; Monitoring tool

Alpha-Agonists

Clonidine Guanfacine

Bradycardia; Hypotention; Heart block

Rule out congenital heart disease; Blood pressure and heart rate

Stimulants

Amphetamines

Serious cardiovascular risk [59]

Blood pressure and heart rate; ECG where there is a question of congenital heart disease

Anticonvulsant-Mood Stabilizer

Divalproex; Valproic acid

Polycystic ovaries in girls; malformation rate of 11.1% compared with 3.1% in non-drug exposed fetuses [62]; hepatotoxicity [63]; pancreatitis [64, 65]

Discuss risks and provide written information before initiating therapy; girls of child-bearing age should be counseled regarding birth control. Close laboratory monitoring of liver enzymes & coagulation tests in the first 6 months; clinical monitoring for vomiting and apathy; blood levels

 

Lamotrigine

Rash requiring hospitalization, possible Stevens Johnson Syndrome or hypersensitivity syndrome; serum concentrations doubled when divalproex was added in adjunctive treatment of epilepsy.

Indication in those younger than 16 is restricted to Lennox Gastaut Syndrome. Black box warning for potentially life threatening rashes

Antidepressants

SSRIs

Activation syndrome, suicidality

A written diary by the parent of target symptoms and selected adverse events is useful. Regular contact to review information when drug or dose is initiated or changed. Monitor side effects and response regularly

 

TCAs

Dose-dependent cardiac conduction delays; asystole

Baseline and follow-up ECG at therapeutic dose, blood levels.

 

Bupropion

Dose-dependent risk of seizure

Consider alternatives in youth with a history of seizure disorders or bulimia

Atypical Antipsychotics

Olanzapine Risperidone Quetiapine Clozapine Ziprasidone

Relatively greater weight gain in youths than in adults Extrapyramidal Side Effects (EPS) Hyperprolactinaemia Possible Hyperthyroidism (Quetiapine)

Baseline and repeat weight, height and waist circumference, serum fasting lipid and hepatic enzyme levels, thyroid panel (for quetiapine). Fasting glucose level monitoring for the risk of diabetes; diet and exercise management. Monitor quarterly or as indicated for movement disorders with the Abnormal Involuntary Movement Scale (AIMS). Prolactin blood level monitoring in the presence of abnormal sexual signs and symptoms.

Lithium

Lithium

Thyroid abnormalities; nephrotoxicity; renal concentration diminution; lithium toxicity

Lithium levels, baseline thyroid panel, serum creatinine and urinalysis. Repeat periodically, and when dose or regimen changes or symptoms suggest toxicity.