Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what aggregated safety data, including adverse-event summaries, the MHRA has recorded relating to the use of puberty blockers in under-18s since 2010; and whether the Department has been informed of any safety signals during that period.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate to inform regulatory decisions.

Puberty blockers are also known as gonadotrophin-releasing hormone (GnRH) analogues. These medicines are licenced for conditions such as young children who enter puberty too early, also known as precocious puberty, prostate cancer, and endometriosis. The use of GnRH analogues to suppress puberty in children and young people with gender dysphoria is off-label prescribing. This means that the use of these medicines for this purpose is outside of the licensed uses, and as such the benefits and risks of the medicine for use in this specific population have not been assessed. The MHRA does not regulate off-label use.

The MHRA has received three United Kingdom suspected adverse drug reaction reports in which a GnRH analogue has been reported as being used in a child or young person for the purpose of puberty suppression in gender dysphoria. The GnRH analogues included in this search were buserelin, leuprorelin, goserelin, gonadorelin, nafarelin, and triptorelin. Please note it is not mandatory to provide information on indication when submitting an adverse drug reaction report.

It is important to note that a reaction reported to the Yellow Card scheme does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. Underlying or concurrent illnesses may be responsible, or the events could be coincidental.

The MHRA has not identified any safety signals which concern the off-label use of the GnRH analogues for the purpose of puberty suppression in gender dysphoria. However, we acknowledge that there is a clear lack of clinical evidence for the safety and efficacy of using these medicines for gender incongruence and/or dysphoria in those aged 18 years old and under. That is why NHS England and the National Institute for Health and Care Research have commissioned a carefully designed clinical trial to assess the relative benefits and harms of puberty suppressing hormones on young people’s physical, social, and emotional well-being.