Antidepressants for treatment of children and adolescents

In continuation of a report on Danish television in ‘DR 21’ on Sunday 1 May 2011 on the risk of suicide from using SSRIs to treat children and adolescents, the Danish Medicines Agency has the following comments:

SSRIs (selective serotonin reuptake inhibitors) are medicines used for the treatment of depression and a number of anxiety disorders.

In Denmark, medicines with six different active substances of the SSRI type have been approved: fluoxetine, citalopram, paroxetine, sertraline, fluvoxamine and escitalopram.

From these products, only some of the fluoxetine-containing products are approved for treatment of depression in children and adolescents (moderate to severe depression in children aged 8 or more).

In addition, a number of products containing sertraline and fluvoxamine are approved for treatment of obsessive-compulsive disorder (OCD), but not approved for treatment of depression in children and adolescents. Other SSRIs are not approved for treatment of children and adolescents.

Generally, a warning on the increased risk of suicide-related behaviour from treatment with SSRIs is placed in the summaries of product characteristics and the package leaflets of medicines that contain SSRIs. Children and adolescents treated with an SSRI should therefore be monitored carefully for the appearance of suicidal symptoms.

Physicians may prescribe the product of their choice

When the Danish Medicines Agency authorises a medicine, the therapeutic indications are established, which appear from the summary of product characteristics. The therapeutic indications describe the diseases, etc. against which the medicine has a proven effect as documented in the application submitted by the marketing authorisation holder. So, even though it may be well-known and – in other contexts proven – that the medicine is also effective on other diseases or in other age groups, it will not appear from the approved therapeutic indications, unless the company has applied for such approval.

A physician in Denmark is allowed to prescribe a medicine for the treatment of a patient, even though the medicine may not be approved for the disease, etc, in question. This follows from their right to prescribe the medicine of their choice. In such a situation, the physician will carefully weigh the expected benefits against any risks for each individual patient.

Regardless of whether or not the medicine is approved for treatment of children and adolescents, physicians who use SSRIs for treatment of this age group must pay attention to the Danish National Board of Health's guidelines on medical treatment of children and adolescents who suffer from a psychiatric disorder (Danish title: ‘Vejledning om medikamentel behandling af børn og unge med psykiske lidelser’ (10 December 2007)). 

New users in the age group 0-17 years in 2010 – broken down by prescriber

Based on information from the Danish Medicines Agency’s Register of Medicinal Product Statistics, we have investigated which types of physicians are registered as having prescribed the first prescription to new users of antidepressants of the SSRI type to children and adolescents under the age of 18 years in 2010 (see the table below). In this context, new users means users who have not redeemed a prescription for a medicine of the SSRI type since 1994. In 2010, altogether 2,802 children and adolescents started treatment for the first time.

The data in the table should be interpreted with caution because the data quality in this area is not optimal. This is because the general practitioner could turn out to appear as the person having prescribed the medicine, even though the prescription was issued by another physician. The reason is that some pharmacy systems automatically register the general practitioner as having prescribed the medicine. The pharmacy staff must subsequently change the information manually afterwards, which could be forgotten. The Danish Medicines Agency does not know the extent of this type of error, but it means that the general practitioners' share of prescriptions is definitely overrepresented compared to that of specialist practitioners and hospital doctors. Also, the data do not reveal whether the general practitioner has consulted a physician specialised in child and adolescent psychiatry in advance of prescribing the medicine.

Sertraline is the most sold product

The table below outlines the sale of SSRI products to children and adolescents by the individual products, regardless of which disease they have been prescribed for. Sertraline is the most sold product from among the SSRIs, and, as mentioned earlier, it is approved for the treatment of children diagnosed with OCD. But the table also reveals a significant sale of SSRI products not authorised for treatment of children and adolescents.

Table showing the sale of SSRI products in 2010 to children and adolescents in Denmark. The figures reflect the number of people having redeemed a prescription:

One suicide attempt has been reported to the Danish Medicines Agency, but in Denmark, there have never been reports of a completed suicide among children and adolescents after taking an SSRI.