UK regulators add stronger boxed warnings for antidepressants on suicide and lasting sexual side effects

Today the Medicines and Healthcare products Regulatory Agency (MHRA) disclosed that antidepressant packaging will carry enhanced boxed warnings highlighting both suicidal thoughts and the possibility of enduring sexual problems after treatment ends. Patient information leaflets will be rewritten to make these hazards more visible and to point users toward support services. The update stems from a Commission on Human Medicines review prompted by complaints from patients and families about how risks are communicated.

Dr Alison Cave, the agency’s chief safety officer, emphasized that the changes are intended to give clearer information while affirming that, for most people, the benefits of antidepressants outweigh the risks when used under medical supervision. The guidance also instructs healthcare professionals to discuss suicidal ideation when starting or changing doses. Evidence cited links drugs such as duloxetine, fluvoxamine and fluoxetine to persistent sexual dysfunction, known as Post-SSRI Sexual Dysfunction, which can last months or years after discontinuation. The new leaflets will reach current users beginning in 2027, and the MHRA cautions against sudden cessation without professional advice.