The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has announced new antidepressant safety measures that expand suicide-risk information to patients of all ages and, for the first time, recognize Post-SSRI Sexual Dysfunction (PSSD) from certain antidepressants, which can persist after the drugs are stopped. The changes follow a review prompted by concerns from patients and families. According to Citizens Commission on Human Rights International (CCHR), a 57-year mental health industry watchdog, the MHRA has once again acted before the U.S. Food and Drug Administration (FDA). CCHR is calling on the FDA to issue equivalent warnings.
The implications for U.S. patients are significant. In the UK, healthcare professionals must now discuss suicide risk and persistent sexual dysfunction when starting antidepressants, changing doses, or reviewing treatment. Patient information leaflets will be updated with boxed warnings to make the risks more prominent. 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. "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.
The FDA's current labeling lags behind. In 2004, almost a year after the MHRA's 2003 warning on SSRI suicide risk in young people, the FDA added a black-box warning for suicidal ideation in those 18 and younger, later extended to age 24—leaving the implication that the risk ends on a person's 25th birthday. Dr. David Healy, professor of psychiatry at Bangor University, 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 2018, Healy and 22 international experts petitioned the FDA to require 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. The FDA has not issued class-wide labeling to match the petition.
Other regulators have acted. In 2019, the European Medicines Agency adopted product information updates warning that SSRIs and SNRIs may cause long-lasting sexual dysfunction that may continue despite discontinuation. In 2021, Health Canada completed a safety review and announced labeling updates to reflect the risk. 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 scale of the issue is substantial: 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. CCHR urges the FDA to align U.S. labeling and patient information with the MHRA's updated measures. Clear, prominent warnings on suicide risk for all ages and on persistent sexual dysfunction would give American patients and families the same information already being provided in the UK and Europe. Until the FDA acts, millions of people taking these drugs are at risk, without the full safety disclosures now required elsewhere.
