Antidepressants are to come with more ‘prominent’ warnings about the risks of suicidal thoughts and behaviours, the medicines regulator has announced. The move follows a number of deaths occurring in the UK.
It comes after it emerged that four prevention of future death reports concerning the prescribing of antidepressants, or their safety information, have been sent to the Medicines and Healthcare Products Regulatory Agency (MHRA) since 2020.
Thomas Kingston inquest raises concerns
Following the death of Thomas Kingston, the husband of Prince and Princess Michael of Kent’s daughter, Lady Gabriella Kingston, it was questioned whether there is ‘adequate communication of the risks of suicide associated with the selective serotonin reuptake inhibitor (SSRI) medications’.
Mr Kingston died at the age of 45 by suicide in 2024. An inquest into his death at Gloucestershire Coroner’s Court said he had been given sertraline, a drug used to treat depression and mental health problems. He was also given zopiclone, a sleeping tablet, by a GP at the Royal Mews Surgery, a practice at Buckingham Palace used by royal household staff, after complaining of trouble sleeping following stress at work.
Returning to the surgery, Mr Kingston was moved from sertraline to citalopram by a doctor after saying the drugs were not making him feel better. Both of these drugs are SSRIs. Prior to his death, Mr Kingston had stopped taking medication and toxicology tests showed caffeine and small amounts of zopiclone in his system.
Senior coroner for Gloucestershire, Katy Skerrett, said in her prevention of future deaths report that Mr Kingston ‘had recently been experiencing anxiety, but had not expressed any suicidal ideation’. Writing to the MHRA about matters of concern arising from the inquest, she asked: “Whether there is adequate communication of the risks of suicide associated with the selective serotonin reuptake inhibitor (SSRI) medications.”
Changes to patient information leaflets
With Ms Skerrett warning that action should be taken to prevent future deaths, Mr Kingston’s parents, Martin and Jill Kingston, called for changes in how patients are prescribed SSRIs. They noted that both the patient and the people close to them should be told more explicitly about the potential side effects of the medication.
A review by the Commission on Human Medicines was conducted after patients and families raised concerns about how information is communicated in patient safety leaflets on suicidal thoughts and behaviours and sexual dysfunction that continues after treatment is stopped.
The MHRA will update patient information leaflets for antidepressants, with a new ‘boxed warning’ containing information on suicidal thoughts and behaviours that they say will ‘make information easier to find’. Additionally, a new patient safety card is expected to be included in or on the medicine box to reinforce safety messaging as well as patient information leaflets for certain antidepressants to be updated to include the term ‘Post SSRI Sexual Dysfunction’ to explain the risk of symptoms continuing after treatment.
MHRA response and next steps
An additional safety leaflet is being developed by the MHRA, which will be given to patients at their first appointment discussing antidepressants when it becomes available in 2027.
Dr Alison Cave, MHRA’s chief safety officer, said: “Patients need clear and accessible information about the benefits and risks of medicines so they can make informed decisions. We are incredibly grateful for the valuable contributions of patients, families, clinicians and experts to this review.
“These measures will help ensure patients, carers and healthcare professionals can have more informed conversations about the benefits and risks associated with antidepressant medicines, and better support people throughout their treatment.
“Antidepressants are effective medicines for the treatment of depression and other conditions. When used appropriately and under clinical supervision, for the vast majority of individuals, the benefits outweigh the risks. The aim is not to discourage use, but to improve the prominence and clarity of the existing warnings. It’s imperative that patients do not stop taking these medicines without first speaking to their healthcare professional.”
Health minister James Frith said earlier this week that revised patient information leaflets and patient cards would be available online from October and hard copies will be in packs around three to six months later. In a written answer to Parliament, Mr Frith noted that in the interim the MHRA is working to evaluate the feasibility for earlier access to hard copies via pharmacies.
Asked about prevention of future death reports, Mr Frith said: “The MHRA logs all Prevention of Future Deaths reports it receives and can confirm that since 2020, four reports concerning the prescribing of antidepressants, or their safety information, have been sent to the MHRA.”
Also issued is a new drug safety update which advises healthcare workers on the information to give to their patients, including what to tell them if they feel suicidal, and the potential for sexual dysfunction with some antidepressants. It’s noted that patients should be told that ‘these are not new risks for these medicines, but it is important to be aware of them’ and they should be advised not to stop taking their medicine without first speaking to your healthcare professional.
