§ Baroness David
asked Her Majesty's Government: What advice they have received from the Committee on Safety of Medicines about the treatment of major depressive disorder in children and adolescents under 18 years. [HL366]
§ Lord Warner
The Department of Health has received new advice from the Committee on Safety of Medicines (CSM) about the use of selective Serotonin re-uptake inhibitors (SSRIs) in children under the age of 18 for the treatment of major depressive disorder (MDD).
An expert working group of the CSM was established earlier this year to look at the safety of the whole class of SSRIs. The group has already advised on paroxetine and the related anti-depressant venlafaxine. It has now concluded that the balance of risks and benefits for the treatment of major depressive72WA
disorder (MDD) in under-18s is unfavourable for the SSRIs sertraline, citalopram and escitalopram and unassessable for fluvoxamine.
This new advice follows announcements in June and September that paroxetine and venlafaxine should not be used in children and adolescents under the age of 18 years to treat depressive illness. Like paroxetine and venlafaxine, none of these drugs has ever been licensed for use in under-18s, but we know they are used in this age group outside licensed indications, where prescribers make a judgment on their own responsibility that it is the right treatment for a particular patient.
Only fluoxetine (Prozac) was shown in clinical trials to have a positive balance of risks and benefits in the treatment of MDD in under-18s. There is no evidence to date to suggest that the risks of treatment outweigh the benefits in adults.
The CSM expert group has delivered comprehensive advice on the use of SSRIs in children and young people following a thorough review of all the evidence available. This represents the most detailed review to be completed so far and gives parents, young people and those who treat these serious illnesses the information they need to make informed decisions about treatment. The expert group will now focus its attention on finishing a complete review of the safety of the entire class of medicines in adults and young adults.
Communications to patients and prescribers are taking place today and copies of these materials have been placed in the Library. The benefits of taking these drugs are well established, but we know that some patients suffer significant side effects. Patients over 18 and patients who are benefiting from SSRIs should not be frightened into stopping their medication abruptly. Patients who are experiencing any side effects or are concerned about their treatment should discuss these with their doctor.
The Government are committed to ensuring that the wider aspects of suicide prevention remain at the top of the agenda and the National Institute for Mental Health in England has made suicide prevention one of its core policy programmes.