Freedom of Information request on the data supporting efficacy and safety of Selective serotonin reuptake inhibitors for aged under 30 diagnosed with anxiety (FOI 22/610)
Published 27 March 2023
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FOI 22/610
10th May 2022
Dear
Thank you for your letter to Dr Raine of 11/04/2022 requesting under the Freedom of Information Act all reports and data held supporting the efficacy and safety of Selective Serotonin Reuptake Inhibitors (SSRIs) in people under the age of 30 diagnosed with anxiety.
The table below summarises the currently licensed SSRI medicines and their current licensed indication.
| SSRI | Date licensed in the UK | Current indication |
|---|---|---|
| Fluvoxamine | 1987 | Major depressive episode Obsessive Compulsive Disorder (OCD) |
| Fluoxetine | 1989 | Adults: Major Depressive Episodes: Fluoxetine is indicated for the treatment of the symptoms of major depressive illness, with or without associated anxiety symptoms, especially where sedation is not required. Obsessive-compulsive disorder. Bulimia nervosa: Fluoxetine is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. Children and Adolescents Ages 8 Years and Above: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with concurrent psychological therapy. |
| Sertraline | 1990 | Major depressive episodes. Prevention of recurrence of major depressive episodes. Panic disorder, with or without agoraphobia. Obsessive compulsive disorder (OCD) in adults and paediatric patients ages 6-17 years. Social anxiety disorder. Post traumatic stress disorder (PTSD) |
| Paroxetine | 1991 | Major Depressive Episodes Obsessive Compulsive Disorder Panic Disorder with and without agoraphobia Social Anxiety Disorder/Social phobia Generalised Anxiety Disorder Post-traumatic Stress Disorder |
| Citalopram | 1995 | Treatment of depressive illness in the initial phase and as maintenance against potential relapse/recurrence. Citalopram is also indicated in the treatment of panic disorder with or without agoraphobia |
| Escitalopram | 2002 | Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder. |
As the table outlines, four SSRIs (Fluoxetine, Sertraline, Paroxetine and Escitalopram) are licensed for use in conditions described as anxiety related disorders although it is recognised that anxiety can form part of the other conditions for which SSRIs are licensed, including Major Depression.
When applying for a licence to market a SSRI for use in anxiety related disorders, the company must submit clinical trial data to demonstrate the medicine is safe and effective in that particular indication.
These data are provided for the entire study population and people with a range of anxiety associated psychiatric illness would be included with a range of ages. Adult studies include patients over the age of 18 years and specific analysis of data in those under the age of 30 may not be available.
In a previous Expert Working Group review in 2003/4 when data were analysed a clear change in the benefit risk was seen at age 25 years for all included antidepressant medicines with the exception of fluoxetine. This led to the advice about monitoring patients particularly under the age of 25 years in early treatment for the risk of suicidal thoughts and related behaviours.
Once approved, the ongoing safety monitoring of SSRIs licensed for anxiety disorders is managed by assessment of worldwide periodic safety update reports, the published literature and weekly signal monitoring activities. These data are not age or indication specific and retrieving these volumes of data and redacting to make them specific to your request relating to people under 30 years and restricted to anxiety alone would not be possible within the time required for a FOI.
MHRA hold a database of Yellow Card reports which can be broken down by age and indication for use but these details are not always provided by the reporter and a manual search of the case narrative would be required. Since the SSRIs have been marketed for a number of years there will be a large volume of Yellow Card reports detailing a wide variety of adverse drug events.
Extracting data and reports of efficacy and safety of Selective Serotonin Reuptake Inhibitors (SSRIs) in people under the age of 30 diagnosed with anxiety for every antidepressant would fall under Section 12 of the FOI Act. We are therefore unable to provide this level of information for each antidepressant.
Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
If your request can be refined, for example by specific medicine or year or a specific safety issue we will be happy to reconsider your FOI request.
We hope the information we have provided will help you refine your request. In addition we thought you would be interested to know that in relation to the safety of SSRI medicines, the Commission on Human Medicines (CHM) has convened an expert working group (EWG) to review of the need for additional risk minimisation associated with the risk of suicide associated with SSRIs.
The Department of Health and Social Care has launched a Call for Evidence this week which asks the public to share views on how support and services should adapt for the future. The details can be found at https://www.gov.uk/government/news/call-for-evidence-for-new-10-year-plan-to-improve-mental-health
I hope the information provided is helpful; however, if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Please remember to quote the reference number above in any future communications.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division