LONDON, Dec. 1 -- The government of the United Kingdom issued the following news:
An Expert Working Group(EWG)of the Commission on Human Medicines (CHM), advisingthe Medicines and Healthcare Products Regulatory Agency (MHRA), has concludedadetailedreview into how thepotentialrisks associated with 28 antidepressant medicines are communicatedto patientswithin the Patient Information Leaflet (PIL).
The reviewwaslaunchedafterconcerns were raisedby families and patients that current safety warningsin thePILsfor these medicinesdid not clearly explain certain side effects -specificallysuicidalbehaviours,and sexual dysfunction that may continue after the treatment is stopped.
Over the past 18 months, the EWG has heard directly from families, patients, and mental health support organisations. The group considered the real-world experiences of those affected,together with the scientific literature, to understand how warnings could be made clearer and moreeasily understood bypatients.
Based on the group'srecommendations, theCHM has advised that the wording in the PILsprovided with antidepressant medicationsshould be strengthened to provide greater clarity on the risk of suicidal behaviour. The revised text will be further developed through user testingto ensureit isas clear andeffectiveas possible, andthe MHRA is exploring a range of engagement options to take this advice forward.
The CHM has also recommended updates to the PILs for certain antidepressants to better reflect patient feedback and emerging evidence on the potential for sexual dysfunction that maycontinueafter stopping treatment.
Severaladditionalcommunication measures have been agreed, including:
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the introduction of a patient cardto be given to patientsby their healthcare professional or included in the medicine packand available digitallyto further highlight the riskofsuicidal behaviour;
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an ancillary leaflet to support discussions between patients and healthcare professionalsregardingthe risk of suicidal behaviourdeveloped with wider healthcare system partners
The MHRA isengagingwiththeNational Institute for Health and Care Excellence (NICE), the British National Formulary (BNF), and the Royal Colleges of General Practice and Psychiatriststo improve consistency of safety messagingin a range ofadditionalcommunications.
The MHRA recognises that many families and patients are waiting tosee the final products that have been developedas a result ofthereview.While regulatory processesareongoing there are limitations in the level of detail the MHRA is able to communicate. As soon asthe regulatory position is finalised,the MHRA is committed to communicatingon the final productsas quickly as possible.
Patients should continue taking their medicines as prescribed and not stop or change treatment without first speaking to a doctor or mental health professional.Please also read the PIL whichcontainsimportant informationabout your medicine.Anyone experiencing side effects should seek medical advice and report suspected side effects via theYellow Card scheme.
Notes to Editors:
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Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), are widely used for the treatment of depression and other mental health conditions. The MHRA rigorouslymonitorsthe safety of these medicines, including side effects and emerging evidence.
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As well as having beneficial effects, antidepressants can cause side effects in some people, and in some cases these can be severe. Details ofpossible sideeffects are provided in the Patient Information Leaflets (PILs) accompanying these medicines.
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All known side effects associated with individual antidepressants are outlined in the Summary of Product Characteristics (SmPC) for healthcare professionals and reflected inlaylanguageinthe PILs which can be found in the medicine packs.
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Ifyou'rehaving suicidal thoughts, help is available now. You can call NHS 111 (24 hours every day), Samaritans on 116 123, or text "SHOUT" to 85258. Find more information and support options on theNHS website.
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TheCommission on Human Medicines (CHM)is an independent statutory body, whose members are appointed directly by ministers. Members are not employees of the Agency and are appointed to advise government (Health Ministers), through the licensing authority (the Medicines and Healthcare products Regulatory Agency (MHRA)).
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TheAntidepressant Risk Minimisation Expert Working Groupwas set uptoadvisethe CHMon any recommendations foradditionalrisk minimisation measures on the risk of suicidal behaviour associated with all antidepressants and sexual dysfunction which maycontinueonstopping treatment.
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The MHRA is an executive agency of the Department of Health and Social Care.
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The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust andevidence-based assessmentsby multi-disciplinary teamsto ensure that the benefits justify any risks.
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For media enquiries, please contactthe newscentre@mhra.gov.uk, or call on 020 30807651.
Disclaimer: Curated by HT Syndication.
