The United Kingdom's Medicines and Healthcare products Regulatory Agency has announced new antidepressant safety measures covering all patients, expanding suicide-risk information beyond the children and young adults who currently receive it and, for the first time, recognizing Post-SSRI Sexual Dysfunction from certain antidepressants—a condition that can continue even after the drugs are stopped. Citizens Commission on Human Rights International (CCHR), a 57-year mental health industry watchdog, says the MHRA has once again acted before the U.S. Food and Drug Administration and is calling on the FDA to issue equivalent warnings.
The significance lies in the gap between regulators. The MHRA is adding "Post SSRI Sexual Dysfunction" to patient information leaflets for citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, amitriptyline and nortriptyline. Listed symptoms include genital numbness, loss of libido, erectile dysfunction and difficulty reaching orgasm. In the UK, healthcare professionals must now discuss suicide risk and persistent sexual dysfunction when starting antidepressants, changing doses or reviewing treatment, and leaflets will carry boxed warnings to make the risks more prominent.
The MHRA's record of moving first is long. In December 2003, it was the first regulator to warn that SSRI antidepressants increased suicide and self-harm risk in young people, a step CCHR attributes to concerns raised by Dr. David Healy, professor of psychiatry at Bangor University. The FDA had relevant data for decades, according to the release: a 1985 memo from the manufacturer of fluoxetine reported a suicide rate for the drug 5.6 times higher than for older tricyclic antidepressants. In 1991, CCHR helped secure an FDA advisory committee hearing into antidepressants causing suicidal ideation and violent behavior; the panel, many of whose members had conflicts of interest with pharmaceutical companies, negated the risks.
The FDA did not add a black-box warning for suicidal ideation in those 18 and younger until October 2004, almost a year after the MHRA's warning, later extending it to age 24—leaving the implication that the risk ends on a person's 25th birthday. Healy warned in 2009 that antidepressants pose a suicide risk in all age groups, citing elevated relative risks for completed suicide in ages 18–64 based on FDA trial data. In 2018, he was among 22 international experts who petitioned the FDA to require prominent warnings that the 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 that petition.
The stakes for American patients are substantial. IQVia Total Patient Tracker Database figures for 2020 revealed that 45,204,771 Americans were taking antidepressants, including 2,154,118 in the 0–17 age group. Other regulators have already moved: the European Medicines Agency adopted product information updates in 2019 warning that SSRIs and SNRIs may cause long-lasting sexual dysfunction despite discontinuation, and Health Canada completed a safety review and announced labeling updates in 2021. Psychiatrist Josef Witt-Doerring, a former FDA medical officer, has reported that many taking antidepressants may experience emotional numbing, loss of sexual sensation and detachment from pleasure that can persist indefinitely, while Harvard's Dr. Joseph Glenmullen warned in Prozac Backlash that SSRIs caused sexual dysfunction in up to 60% of users.
CCHR urges the FDA to align U.S. labeling and patient information with the MHRA's updated measures, arguing that clear, prominent warnings on suicide risk for all ages and on persistent sexual dysfunction would give American patients and families the same information already provided in the UK and Europe. Until the FDA acts, the group says, millions of people taking these drugs remain without the full safety disclosures now required elsewhere.
