Table 2

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

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


*Indication for use not listed, but recorded as "Maternal drugs affecting foetus"; NA: not available

Aagaard and Hansen BMC Research Notes 2010 3:176   doi:10.1186/1756-0500-3-176

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