MHRA orders stronger antidepressant warnings on suicidal thoughts and lasting sexual side effects

Mixed · 2The Medicines and Healthcare products Regulatory Agency (MHRA) announced on 15 October 2026 that antidepressants will come with more prominent warnings about suicidal thoughts and behaviours, and clearer information on sexual side effects. 1 2 Left · 1Patient information leaflets will be updated with a new boxed warning on suicidal thoughts and behaviours, and a patient safety card is expected to be included in or on the medicine box. 1 Mixed · 2Leaflets for certain antidepressants will also use the term "Post SSRI Sexual Dysfunction" (PSSD) to explain the risk of symptoms continuing after treatment stops. 1 3

Right · 1The Daily Mail reports that the MHRA named duloxetine, fluvoxamine and fluoxetine as associated with sexual dysfunction that may continue after treatment, and that mirtazapine, vortioxetine and agomelatine were not included in the updated warning. 2 Mixed · 2The changes follow a review by the Commission on Human Medicines, prompted by patients and families raising concerns about how leaflets communicate these risks. 1 2 Left · 1The Daily Mirror adds that four prevention of future death reports concerning the prescribing of antidepressants or their safety information have been sent to the MHRA since 2020, according to health minister James Frith in a written parliamentary answer. 1

Mixed · 2Dr Alison Cave, the MHRA's chief safety officer, said patients need clear information to make informed decisions, that the benefits outweigh the risks for the vast majority of people, and that "the aim is not to discourage use, but to improve the prominence and clarity of the existing warnings". 1 2 Mixed · 2The MHRA stressed that people should not stop taking antidepressants without first speaking to a healthcare professional, and a new drug safety update tells clinicians to say these are not new risks. 1 2 Mixed · 2On timing, the Mirror says Mr Frith told Parliament revised leaflets and cards would be online from October with hard copies in packs around three to six months later, and that a separate MHRA safety leaflet for first appointments is due in 2027; the Mail says patients already on antidepressants will receive updated leaflets when they become available in 2027. 1 2

Right · 1The Mail says the PSSD condition has been disputed for years, with some doctors questioning whether persistent sexual problems come from the drugs or from underlying mental health conditions, and describes the change as the first time regulators have explicitly acknowledged that the dysfunction can persist; it also notes that sexual side effects and suicidal-thought warnings are not new. 2 Right · 1A separate Mail feature features Katie Collingwood, 35, who says she has had symptoms since taking fluoxetine in her early twenties and was privately diagnosed with PSSD last year; experts quoted there describe PSSD as rare and the cause as unknown. 3 Right · 1The Mail puts antidepressant use at around one in seven adults, citing NHS data, and in its feature at nearly nine million Britons. 2 3