The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has announced new antidepressant safety measures for all patients, requiring clearer suicide-risk information across all age groups and, for the first time, recognizing Post-SSRI Sexual Dysfunction (PSSD) from certain antidepressants, which can continue even after the drugs are stopped. The changes follow a review prompted by concerns from patients and families. Citizens Commission on Human Rights International (CCHR), a 57-year mental health industry watchdog, points out that the MHRA has once again acted before the U.S. Food and Drug Administration (FDA) and calls on the FDA to issue equivalent warnings.
The implications for U.S. patients are significant. The MHRA is adding "Post SSRI Sexual Dysfunction" to patient information leaflets for citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, amitriptyline, and nortriptyline. Symptoms include genital numbness, loss of libido, erectile dysfunction, and difficulty reaching orgasm. In the U.S., psychiatrist Josef Witt-Doerring, a former FDA medical officer, reported that many taking antidepressants may experience emotional numbing, loss of sexual sensation, and detachment from pleasure—effects that can persist indefinitely. Harvard's Dr. Joseph Glenmullen warned in Prozac Backlash that SSRIs caused sexual dysfunction in up to 60% of users.
The FDA has not issued class-wide labeling to match a 2018 citizen petition by Dr. David Healy and 22 international experts, which urged prominent warnings that these drugs can reduce genital sensitivity—sometimes within 30 minutes of the first dose—with effects that may last for years or indefinitely after discontinuation. Other regulators have acted: in 2019, the European Medicines Agency adopted product information updates to warn that SSRIs and SNRIs may cause long-lasting sexual dysfunction that may continue despite discontinuation of treatment. In 2021, Health Canada completed a safety review and also announced updates to the labeling and product safety information to reflect the risk.
The scale of the affected population underscores the stakes. IQVia Total Patient Tracker Database for 2020 revealed 45,204,771 Americans were taking antidepressants, including 2,154,118 in the 0-17 age group. Until the FDA acts, millions of people taking these drugs are at risk, without the full safety disclosures now required elsewhere. CCHR urges the FDA to align U.S. labeling and patient information with the MHRA's updated measures, which would give American patients and families the same information already being provided in the UK and Europe.
The MHRA's action also expands suicide-risk warnings beyond the current U.S. black-box warning, which is limited to those 18 and younger and was later extended to age 24—leaving the implication that the risk ends on a person's 25th birthday. Dr. Healy warned in 2009 that "antidepressants pose a risk of suicide in all age groups," citing elevated relative risks for completed suicide in ages 18–64 based on FDA trial data. In the UK, healthcare professionals must now discuss suicide risk and persistent sexual dysfunction when starting antidepressants, changing doses, or reviewing treatment. UK Health chiefs announced that patient information leaflets will be updated to make the risks more prominent through the use of boxed warnings. "Patients need clear and accessible information about the benefits and risks of medicines so they can make informed decisions," Dr Alison Cave, chief safety officer at the MHRA, said.
