“In light of the scientific data which to date remain inconclusive on the benefit-risk relationship for adolescents with gender dysphoria disorder, AIFA remains vigilant and sensitive to the evolution of the international scientific context and will initiate a discussion and reassessment on the inclusion of triptorelin in the list of established medicines pursuant to law 648 of 1996, in agreement with the establishment of the Ministry of Health and with the main scientific societies involved, the Italian Society of Endocrinology, the Italian Society of Andrology and Sexual Medicine, and the Italian Society of Endocrinology and pediatric diabetology. Science is constantly evolving and more in-depth experimental and clinical evidence is needed to support the use of triptorelin in adolescents with gender dysphoria”. Robert Giovanni Nisticò, president of the Italian Medicines Agency (Aifa), said this at the hearing to the Social Affairs Committee of the Chamber as part of the joint discussion of the resolutions on the definition of guidelines on gender dysphoria.
“We need to address this delicate topic with a rigorous scientific method and ‘evidence based'”, he underlined, announcing that a meeting with all interested scientific societies will be held on 23 May.
The data
“The number of subjects treated with triptorelin in the individual regions based on the data received from AIFA for the year 2023 is approximately 25 – said Nisticò – It is possible that these cases are overestimated due to possible cases of duplication even in the face of interregional mobility. Furthermore, it is not possible to exclude with certainty that the subjects identified are all attributable to the condition of gender dysphoria”.
“The Careggi hospital has sent to Aifa and the Tuscany Region on a quarterly basis an overall file relating to all patients followed by the Departmental Structure of Andrology, Endocrinology, Gender Incongruence and subjected to hormonal treatment, including triptorelin, and also shared in ministerial inspection site. The structure of the file does not allow an easy distinction between the various categories of subjects, i.e. adolescents with gender dysphoria compared to adults with a transgender path or compared to other subjects being treated for similar conditions. Nor among subjects in charge of the Tuscany Region coming from other regions. The data confirmed the absence of safety signals following endocrinological checks of the entire group of patients, while no information was present regarding psychological or psychiatric evaluations“, said the president of the Italian Medicines Agency.
“In the last 3 years the Tuscany Region has not sent to Aifa the aggregate quarterly file with the expenditure data, the file with the clinical monitoring divided by indication. This makes it complex, if not impossible, to correctly identify the region of origin of the subjects included in the file sent to Careggi – he remarked – Aifa has constantly verified the absence of safety signals relating to triptorelin for the treatment of gender dysphoria, which was last updated in the pharmacovigilance network in April 2024 photographs the situation until the end of January 2024, does not report any reports regarding triptorelin for gender dysphoria in the 10-18 age group”.
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