The Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that antidepressants in the UK will now come with more prominent warnings about the risks of suicidal thoughts and behaviours. The update follows the receipt of four prevention of future death reports concerning the prescribing of antidepressants or their safety information since 2020.
The regulator also said side effects linked to sexual dysfunction will be made clearer under the new rules. The changes come after a review by the Commission on Human Medicines, prompted by concerns raised by patients and families about how information on suicidal thoughts and behaviours and sexual dysfunction that continues after treatment is stopped is communicated in patient safety leaflets.
What the updates include
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, the MHRA added.
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. 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 advice
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.”
Drug safety update issued
Earlier this week, health minister James Frith said that revised patient information leaflets and patient cards would be available online from October, with hard copies 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, 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, advising 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”.
