The prescribing of psychotropic medicines for the paediatric population is rapidly increasing. Detailed information about the characteristics of adverse drug reactions (ADRs) to these agents in the general paediatric population is lacking and little evidence has been reported about safety and long-term effects of these medicines in practice. This paper reports on an analysis of all spontaneous ADR reports for psychotropic medicines in Denmark from 1998 to 2007 for children from birth to 17 years of age

The following findings were reported:

• 429 ADRs were reported for psychotropic medicines and 56% of these were classified as serious.

• Almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported in adolescents, especially for antidepressants and psychostimulants.

• Approximately 60 % of ADRs were reported for boys.

• 40% of all ADRs were from the category 'nervous and psychiatric disorders'.

• All but one ADR reported for children below two years of age were serious and two of these were fatal.

• A number of serious ADRs reported in children from birth up to 2 years of age were presumably caused by mothers' use of psychotropic medicines during pregnancy.

• The largest share of ADRs (42%) was reported for psychostimulants followed by 31% for antidepressants and 24% for antipsychotics.

The authors conclude from these findings that the “high number of serious ADRs reported for psychotropic medicines in the paediatric population should be a concern for health care professionals and physicians. Considering the higher number of birth defects being reported greater care has to be given while prescribing these drugs for pregnant women.”