Rachel V Thomas

Health and Me

UK Antidepressants to Carry New Warnings on Suicide Risk, Sexual Side Effects

The UK’s <span>Medicines</span> and Healthcare products Regulatory Agency (<span>MHRA</span>) has introduced new measures to improve how the risks of <span>suicidal thoughts</span> and behaviors and persistent sexual dysfunction are communicated to people taking <span>antidepressants</span>.

Following a review involving patients and their families, the MHRA will introduce a boxed warning in patient information leaflets (PILs), a patient safety card, and an additional safety leaflet. The term “post-SSRI sexual dysfunction” (PSSD) will also be added to the leaflets for certain antidepressants.

“Patients need clear and accessible information about the benefits and risks of medicines so they can make informed decisions,” Dr. Alison Cave, MHRA chief safety officer, said.

She said the changes would support informed discussions among patients, caregivers, and healthcare professionals. Dr. Cave added that <a href="https://www.healthandme.com/health-news/ssris-robert-f-kennedy-jr-launches-new-plan-to-limit-antidepressant-prescriptions-in-the-us-article-154265554" data-type="tilCustomLink">antidepressants </a> can effectively treat depression when used appropriately and under clinical supervision. Patients should not stop taking these medicines without first consulting their healthcare professional.

<h2>What Are the New Antidepressant Warnings?</h2>

Also read: <a href="https://www.healthandme.com/health-wellness/glp-1-drugs-may-offer-mental-health-benefits-reduce-schizophrenia-relapses-lancet-study-article-156345910" data-type="tilCustomLink">GLP-1 Drugs May Offer Mental Health Benefits, Reduce Schizophrenia Relapses: Lancet Study</a>

Patient information leaflets will feature a boxed warning directing readers to information about suicidal thoughts and behaviors, making the guidance easier to find.

A patient safety card is expected to accompany medicine packaging, reinforcing key safety messages and explaining when and how to seek support.

For certain antidepressants, updated leaflets will include information on PSSD, highlighting the possibility that sexual dysfunction may persist after treatment ends.

The MHRA is also developing an additional safety leaflet with the wider healthcare system. Expected in 2027, it will explain the benefits and risks of antidepressant treatment to support informed decisions. It will be given to patients at their first appointment discussing antidepressants and to those already receiving treatment.

<h2>Concerns Over <span rel="noindex">SSRI</span> Safety Warnings</h2>

The MHRA has received four prevention of future deaths reports since 2020 concerning antidepressant prescribing and safety information. One followed the 2024 death by suicide of <span>Thomas Kingston</span>, husband of <span>Lady Gabriella Kingston</span>, at age 45.

An inquest heard that Kingston had been prescribed sertraline and later switched to citalopram after reporting that his medication was not helping. Both are selective serotonin reuptake inhibitors (SSRIs). He had also received the sleeping tablet zopiclone for sleep difficulties and had stopped taking his medication before his death.

Gloucestershire senior coroner Katy Skerrett questioned whether patients were adequately informed about the suicide risks associated with SSRIs. Kingston’s parents called for clearer communication of potential side effects to patients and their families.

<strong>Read More</strong>:  <a href="https://www.healthandme.com/health-wellness/world-mental-health-day-ai-chatbots-may-be-changing-how-children-seek-emotional-support-article-156310814" data-type="tilCustomLink">AI Chatbots May Be Changing How Children Seek Emotional Support</a>

<h2>What Should Healthcare Professionals Do?</h2>

The MHRA advises healthcare professionals to:

<ul><li>Discuss the risk of suicidal thoughts and behaviors when starting antidepressants, changing doses, and during subsequent reviews.</li><li>Explain that some antidepressants can cause sexual dysfunction that may continue after treatment stops.</li><li>Follow relevant National Institute for Health and Care Excellence (NICE) guidance and monitor patients regularly after treatment begins.</li><li>Provide the additional safety leaflet when it becomes available in 2027.</li><li>Report suspected adverse reactions through the MHRA’s Yellow Card scheme.</li></ul>

<h2>What Should Patients Taking Antidepressants Know?</h2>

Patients experiencing new or worsening suicidal thoughts should seek urgent medical attention, particularly when starting treatment or changing their dose. In the UK, they can contact NHS 111, their local mental health crisis team, Samaritans on 116 123, or the SHOUT text service at 85258.

Anyone concerned about sexual dysfunction during or after antidepressant treatment should contact their healthcare professional.

The MHRA said these are not new risks associated with the medicines. Patients should read the information supplied with their medication and consult their healthcare professional before stopping treatment.

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new measures to improve how the risks of suicidal thoughts and behaviors and persistent sexual dysfunction are communicated to people taking antidepressants.Following a review involving patients and their families, the MHRA will introduce a boxed warning in patient information leaflets (PILs), a patient safety card, and an additional safety leaflet. The term “post-SSRI sexual dysfunction” (PSSD) will also be added to the leaflets for certain antidepressants.“Patients need clear and accessible information about the benefits and risks of medicines so they can make informed decisions,” Dr. Alison Cave, MHRA chief safety officer, said.She said the changes would support informed discussions among patients, caregivers, and healthcare professionals. Dr. Cave added that antidepressants  can effectively treat depression when used appropriately and under clinical supervision. Patients should not stop taking these medicines without first consulting their healthcare professional.What Are the New Antidepressant Warnings?Also read: GLP-1 Drugs May Offer Mental Health Benefits, Reduce Schizophrenia Relapses: Lancet StudyPatient information leaflets will feature a boxed warning directing readers to information about suicidal thoughts and behaviors, making the guidance easier to find.A patient safety card is expected to accompany medicine packaging, reinforcing key safety messages and explaining when and how to seek support.For certain antidepressants, updated leaflets will include information on PSSD, highlighting the possibility that sexual dysfunction may persist after treatment ends.The MHRA is also developing an additional safety leaflet with the wider healthcare system. Expected in 2027, it will explain the benefits and risks of antidepressant treatment to support informed decisions. It will be given to patients at their first appointment discussing antidepressants and to those already receiving treatment.Concerns Over SSRI Safety WarningsThe MHRA has received four prevention of future deaths reports since 2020 concerning antidepressant prescribing and safety information. One followed the 2024 death by suicide of Thomas Kingston, husband of Lady Gabriella Kingston, at age 45.An inquest heard that Kingston had been prescribed sertraline and later switched to citalopram after reporting that his medication was not helping. Both are selective serotonin reuptake inhibitors (SSRIs). He had also received the sleeping tablet zopiclone for sleep difficulties and had stopped taking his medication before his death.Gloucestershire senior coroner Katy Skerrett questioned whether patients were adequately informed about the suicide risks associated with SSRIs. Kingston’s parents called for clearer communication of potential side effects to patients and their families.Read More:  AI Chatbots May Be Changing How Children Seek Emotional SupportWhat Should Healthcare Professionals Do?The MHRA advises healthcare professionals to:Discuss the risk of suicidal thoughts and behaviors when starting antidepressants, changing doses, and during subsequent reviews.Explain that some antidepressants can cause sexual dysfunction that may continue after treatment stops.Follow relevant National Institute for Health and Care Excellence (NICE) guidance and monitor patients regularly after treatment begins.Provide the additional safety leaflet when it becomes available in 2027.Report suspected adverse reactions through the MHRA’s Yellow Card scheme.What Should Patients Taking Antidepressants Know?Patients experiencing new or worsening suicidal thoughts should seek urgent medical attention, particularly when starting treatment or changing their dose. In the UK, they can contact NHS 111, their local mental health crisis team, Samaritans on 116 123, or the SHOUT text service at 85258.Anyone concerned about sexual dysfunction during or after antidepressant treatment should contact their healthcare professional.The MHRA said these are not new risks associated with the medicines. Patients should read the information supplied with their medication and consult their healthcare professional before stopping treatment.

uk antidepressants to carry new warnings on suicide risk, sexual side effects

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