Skip to main content

Advertisement

Table 2 Serious ADRs from psychotropic medicines reported for children below two years of age (1998 to 2007)

From: Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade

ATC Medicines Adverse drug reaction No Indication of use Age ofchild
N05A Levopromazine Priapism 1 Headache 0
  Olanzapine Atrial septal defects 1 NA 1
   Blood glucose decreased 1 Schizophrenia 0
   Convulsion 1 NA 0
   Decreased appetite 1 Schizophrenia 0
   Drug exposure during pregnancy 1 NA* 0
   Failure to thrive 1 Schizophrenia 0
   Feeding disorder, neonatal 1 Schizophrenia 0
   Haemoglobin increased 1 NA 1
   Hypoxia 1 NA 0
   Pneumonia 1 NA 1
   Polycythaemia 1 NA 1
   Somnolence 1 Schizophrenia 0
   Tension 1 NA 1
  Risperidon Drug withdrawal syndrome, neonatal 1 Depression 0
  Sulpirid Agitation, neonatal 1 Depression 0
  Zuclopemthixol Supraventricular tachycardia 1 Schizophrenia 0
N05B Buspirone Ventricular septal defect 1 Depression 0
  Diazepam Apnoea 1 Convulsions 0
  Oxazepam Congenital acrochordon 1 Anxiety depression 0
   Chondropathy 1 Anxiety depression 0
   Drug exposure during pregnancy 1 Anxiety depression 0
N06A Amitriptyline Epilepsy 1 Depression 0
   Febrile convulsion 1 Depression 0
  Clompipramine Psychomotor retardation 1 NA 0
  Citalopram Tremor, neonatal 3 Panic disorder 1
   Drug withdrawal syndrome, neonatal 2 Depression/Panic disorder 0/1
   Hypotonia, neonatal 2 Depression 0
   Irritability 2 Panic disorder 0/1
   Apnoea 1 NA* 0
   Asthenia 1 NA 0
   Chorioamnionitis 1 Depression 0
   Convulsion, neonatal 1 Depression 0
   Hypertonia 1 Panic disorder 1
   Hypocalcaemia 1 Depression 0
   Neonatal asphyxia 1 Depression 0
   Neonatal respiratory depression 1 NA* 0
   Oral candidiasis 1 Depression 0
   Pallor 1 NA* 0
   Premature labour 1 Depression 0
   Ventricular septal defect 1 Depression 0
  Escitalopram Atrial septal defect 1 NA 1
   Drug exposure during pregnancy 1 NA* 0
  Fluoxetine Drug withdrawal syndrome, neonatal 3 Depression 0
   Tremor 2 Depression 0
   Agitation, neonatal 1 Depression 0
   Bradycardia, neonatal 1 Depression 0
   Deafness neurosensory 1 NA 0
   Drug exposure during pregnancy 1 NA* 0
   Dyskinesia, neonatal 1 Depression 0
   Feeding disorder, neonatal 1 Depression 0
   Hypertonia, neonatal 1 Depression 0
   Neonatal disorder 1 Depression 0
   Persistent foetal circulation 1 Depression 0
   Upper limb deformity 1 Depression 0
  Paroxetine Klinefelter's syndrome 1 NA 0
   Neonatal respiratory failure 1 NA* 0
   Psychomotor retardation 1 NA 0
  Sertraline Respiration abnormal 2 Depression 0
   Cerebral palsy 1 Depression 0
   Circulatory collapse 1 Depression 0
   Cyanosis 1 Depression 0
   Drug withdrawal syndrome, neonatal 1 Depression 0
   Drug exposure during pregnancy 1 Depression 0
   Muscle spasms 1 Anxiety 0
   Myoclonus 1 Anxiety 0
   Persistent foetal circulation 1 Depression 0
   Pulmonary hypertension 1 Depression 0
  Mirtazapine Cerebral palsy 1 Depression 0
  Venlafaxine Agitation, neonatal 1 Depression 0
  1. *Indication for use not listed, but recorded as "Maternal drugs affecting foetus"; NA: not available