Antidepressants are to come with more “prominent” warnings about risks of suicidal thoughts and behaviours, the medicines regulator has announced. 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.
Coroner's report after Thomas Kingston's death
The prevention of future deaths report issued after the death of Thomas Kingston, the husband of Prince and Princess Michael of Kent’s daughter, Lady Gabriella Kingston, questioned whether there is “adequate communication of the risks of suicide associated with the selective serotonin reuptake inhibitor (SSRI) medications”.
Mr Kingston died by suicide in 2024 when he was 45 years old. The inquest into his death at Gloucestershire Coroner’s Court was told he had been given sertraline, a drug used to treat depression and mental health problems, and 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.
Changes to patient information leaflets
Mr Kingston returned to the surgery saying the drugs were not making him feel better and his doctor moved him from sertraline to citalopram. Both of these drugs are SSRIs. In the days leading up to his death, Mr Kingston had stopped taking medication and toxicology tests showed caffeine and small amounts of zopiclone in his system.
In her prevention of future deaths report, senior coroner for Gloucestershire, Katy Skerrett, said that Mr Kingston “had recently been experiencing anxiety, but had not expressed any suicidal ideation”. She wrote to the MHRA saying that matters of concern arising from the inquest include: “Whether there is adequate communication of the risks of suicide associated with the selective serotonin reuptake inhibitor (SSRI) medications.”
She warned 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, saying that both the patient and the people close to them should be told more explicitly about the potential side effects of the medication, including what can happen if they stop taking it.
The changes announced by the MHRA follow a review by the Commission on Human Medicines, which took place 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.
Patient information leaflets for antidepressants will be updated, including a new “boxed warning” with information on suicidal thoughts and behaviours, “making information easier to find”, the regulator said. A new patient safety card is expected to be included in or on the medicine box to reinforce safety messaging, MHRA added.
And patient information leaflets for certain antidepressants will be updated to include the term “Post SSRI Sexual Dysfunction” to explain the risk of symptoms continuing after treatment. Meanwhile, 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.
Regulator's response and next steps
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.”
Earlier this week, health minister James Frith said 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. He said in a written answer to Parliament 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 – which coroners write if they are concerned future deaths may occur – Mr Frith added: “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.”
A new drug safety update has also been issued on the topic, 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.
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: “Do not stop taking your medicine without first speaking to your healthcare professional”.
When life is difficult, Samaritans are available day or night, 365 days a year. You can call them for free on 116 123 or visit samaritans.org.
