The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has announced new antidepressant safety measures for all patients, following a review prompted by concerns from patients and families. The changes require clearer suicide-risk information for patients of all ages, which is currently limited to children and young adults. For the first time, the measures also recognize Post-SSRI Sexual Dysfunction (PSSD) from certain antidepressants, a condition that can continue even after the drugs are stopped. 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 of this regulatory divergence are significant for American patients. The MHRA was the first regulator to warn in December 2003 that SSRI antidepressants increased suicide and self-harm risk in young people, a move prompted by Dr. David Healy, professor of psychiatry at Bangor University. The FDA added a black-box warning for suicidal ideation in those 18 and younger nearly a year later, later extended to age 24, leaving the implication that the risk ends at age 25. Dr. Healy warned in 2009 that antidepressants pose a suicide risk across all age groups, citing elevated relative risks for completed suicide in ages 18–64 based on FDA trial data. The FDA has had relevant data for decades; a 1985 memo from the manufacturer of fluoxetine reported a suicide rate 5.6 times higher than for older tricyclic antidepressants.
On persistent sexual dysfunction, 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 2018, Dr. 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 that petition. Other regulators have acted: the European Medicines Agency adopted product information updates in 2019, and Health Canada announced labeling updates in 2021.
In the UK, healthcare professionals must now discuss suicide risk and persistent sexual dysfunction when starting antidepressants, changing doses, or reviewing treatment, and patient leaflets will feature boxed warnings. The scale of the U.S. population affected underscores the stakes: according to the IQVia Total Patient Tracker Database for 2020, 45,204,771 Americans were taking antidepressants, including 2,154,118 in the 0–17 age group. CCHR argues that until the FDA aligns U.S. labeling with the MHRA's measures, millions of patients are without the full safety disclosures now required elsewhere.
