Freedom of Information request on the relation to causing suicidal ideation and behaviour (FOI 21/1210)
Published 31 May 2022
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FOI 21/1210
10th December 2021
Dear
Thank you for your emails dated 27th October and 9th November 2021, in which you requested the information held by the MHRA in relation to antidepressants causing suicidal ideation and behaviour. You asked, in particular, for MHRA conclusions on the ‘link’ between antidepressant use and suicidal ideation and behaviour.
There are several different types of antidepressants available on prescription in the UK. These include: Selective serotonin reuptake inhibitors (SSRIs), Serotonin-noradrenaline reuptake inhibitors (SNRIs), Noradrenaline and specific serotonergic antidepressants (NASSAs), Tricyclic antidepressants (TCAs), Serotonin antagonists and reuptake inhibitors (SARIs) and Monoamine oxidase inhibitors (MAOIs). For each type of antidepressant there may be multiple different medicines.
Every authorised medicine has product information which consists of the Summary of Product Characteristics (SmPC) and the patient leaflet that is supplied in the pack of medicine. The product information outlines how to use the medicine and includes details of the possible side effects. The product information for each medicine can be accessed on the MHRA’s website as well as other sources such as the electronic Medicines Compendium.
The safety of all medicines is continuously monitored and the product information may be updated at any time, if new data emerge which indicate an amendment should be made such as a new possible side effect or additional information about an existing side effect.
Although we hold or have access to information on each medicine and the data used to support the warnings in the product information for these medicines, extracting this information 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.
However, you may be interested in our summary of the reviews undertaken by MHRA into the risk of suicide and related events associated with SSRIs and SNRIs antidepressants which is available on our website.
In addition, the issue was reviewed by the independent experts of the Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines in November 2019. It was concluded that the current advice in the product information for antidepressants relating to the risk of suicidal ideation and behaviours and the need to carefully monitor patients for new or worsening symptoms of depression remains extant and reflects data available. The data relating to this important area of safety monitoring remain under continual review by MHRA and the need for regulatory action is regularly reassessed.
I hope you were able to find the information on the number of Yellow Card reports received reporting suicidal ideation and behaviour from the link to the IDAPs provided on 9 November 2021, for each of the antidepressants you are interested in. The IDAPs are dynamic and updated monthly with the latest information from the Yellow Card scheme.
I also hope that you find the summary information useful and you are able to review the specific warnings for the antidepressants you are interested in.
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 restricted, for example to specific antidepressants rather than every medicine within the class of medicines, then we will be happy to reconsider your FOI request and provide you with this information.
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