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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