Trial into puberty blockers for children paused over 'wellbeing concerns'
The MHRA halted recruitment for the Pathways trial after safety reviews found unquantified long-term risks and recommended raising the minimum participant age to 14.
- On Friday the Medicines and Healthcare Products Regulatory Agency paused the PATHWAYS trial and halted recruitment until concerns are resolved, and it will meet King’s College London next week to discuss amendments.
- Because the MHRA flagged unquantified long‑term risks, regulators re‑examined the PATHWAYS trial design after the Cass Review recommended restricting puberty blockers to research settings due to weak evidence.
- MHRA advisers urged stronger bone‑density monitoring and tougher consent safeguards, recommending a graded approach starting at 14 as proposed lower limit for participants aged 10 to almost 16.
- Campaigners and litigants, including JK Rowling, launched legal challenges that intensified scrutiny, while the Department of Health and Social Care and King’s College London said the trial will restart only if experts deem it safe and necessary.
- MHRA will hold scientific discussions with the trial sponsor next week and any amendments must be reviewed by the Research Ethics Committee before restarting the PATHWAYS trial.
22 Articles
22 Articles
UK Puberty Blocker Trial Halted Over Safety Fears
A controversial NHS-backed trial giving puberty blockers to children as young as eight has been dramatically halted after Britain’s medicines watchdog intervened over safety fears. The Medicines and Healthcare products Regulatory Agency (MHRA) has pressed pause on the Pathways study, warning of potentially “significant” and unquantified long-term harms. Officials are now demanding urgent talks with trial leaders at King’s College London, includi…
UK Puberty Blocker Trial Finally Halted Over Significant Safety Concerns
A shocking NHS-supported trial has now been suspended following officials’ warnings of “significant” long-term harms to young people. The controversial plans aimed to give puberty blockers to children as young as eight-years-old, but the […] The post UK Puberty Blocker Trial Finally Halted Over Significant Safety Concerns first appeared on The Expose.
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Great Yorkshire RadioTrial into puberty blockers for children paused over 'wellbeing concerns'
Recruitment to the study will be postponed until the issues have been resolved with the sponsor, King's College, and it is concluded that it is "both safe and necessary", a spokesperson for the Department of Health and Social Care.
Puberty blockers trial paused over concerns from medicines watchdog
Puberty blockers trial paused over concerns from medicines watchdog A clinical trial assessing the risks and benefits of puberty-blocking drugs in children who question their gender has been paused after safety concerns were raised by the UK medicines watchdog. The Medicines and Healthcare…
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