Psychiatric adverse drug reactions to glucocorticoids in children and adolescents: a much higher risk with elevated doses

Psychiatric and behavioural adverse drug reactions (ADRs) to glucocorticoids, especially when used at high dose, are multiple, unforeseeable and extend to a large spectrum of psychopathological disturbances [1–4]. Such high-dose glucocorticoids are frequently prescribed for children with chronic diseases such as asthma, nephrotic syndrome or following organ transplantation. The present study to evaluate the occurrence of psychiatric and/or behavioural ADRs in children was performed using data obtained from the French Pharmacovigilance Database (FPD) to identify spontaneous reports containing such ADRs induced by glucocorticoids in children and adolescents (age < 18 years). The French Pharmacovigilance System was first established in 1973 and consists of a network of 31 Regional Centres. The FPD was established in 1985 to record spontaneous reporting of ADRs. Furthermore, reporting ‘serious’ or ‘unlabelled’ ADRs to the French Regional Centres has been mandatory for any drug prescriber, physician, dentist or midwife in France since 1995 [5]. Despite this obligation, the reporting rate of ADRs in France remains very low. It is estimated at about 5–10% for ‘serious’ ADRs [6]. Spontaneous reports submitted to the FPD, in which glucocorticoids were suspected for psychiatric and/or behavioural ADRs in patients