UK Adds Antidepressant Suicide and PSSD Warnings, CCHR Urges FDA to Follow

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has announced new antidepressant safety measures that, for the first time, recognize Post-SSRI Sexual Dysfunction (PSSD) and require clearer suicide-risk information for patients of all ages, not just children and young adults. The move follows a review prompted by patient and family concerns and affects antidepressants including citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, amitriptyline, and nortriptyline. The MHRA's action has been welcomed by Citizens Commission on Human Rights International (CCHR), a 57-year mental health industry watchdog, which notes that the UK regulator has once again acted before the U.S. Food and Drug Administration (FDA). CCHR is calling on the FDA to issue equivalent warnings.

The news release traces a long history of regulatory divergence. In December 2003, the MHRA became the first regulator to warn that SSRI antidepressants increased suicide and self-harm risk in young people, following concerns raised by Dr. David Healy, professor of psychiatry at Bangor University. The FDA 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—yet only added a black-box warning for suicidal ideation in those 18 and younger in October 2004, almost a year after the MHRA's warning, later extending it to age 24. Dr. Healy warned in 2009 that antidepressants pose a suicide risk in all age groups, and in 2018 he and 22 international experts petitioned the FDA to require warnings about persistent sexual dysfunction, which can include genital numbness, loss of libido, erectile dysfunction, and difficulty reaching orgasm. 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 information leaflets will be updated with boxed warnings. Dr. Alison Cave, chief safety officer at the MHRA, said, "Patients need clear and accessible information about the benefits and risks of medicines so they can make informed decisions." The release also highlights that 45,204,771 Americans were taking antidepressants in 2020, 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, arguing that until it does, millions of people taking these drugs are at risk without the full safety disclosures now required elsewhere. CCHR was established in 1969 by the Church of Scientology and professor of psychiatry Thomas Szasz to investigate and expose psychiatric human rights abuses.