Endocrine Abstracts

Background

Only limited data are available regarding adverse effects of gender affirming hormonal treatment (HT) mainly due to the lack of population-based studies with adequate controls, thus making spontaneous reporting systems a valuable tool to detect potential side reactions.

Objective

In this nationwide retrospective study, we aimed to analyse adverse drug reactions (ADRs) in relation to gender affirming HT reported in the French pharmacovigilance database by patients and by health care professionals and to categorize the type of ADRs.

Research design and methods

We requested for all the individual case safety reports related to gender affirming HT recorded in the French pharmacovigilance database (FPVD) before the 27th of May 2020. An endocrinologist and a pharmacologist reviewed all cases. We excluded cases that have already been published or for which gender affirming HT was not the suspected drug.

Results

A total of 38 reports of ADRs were identified. We excluded 5 cases where gender affirming HT was not the suspected drug and 5 cases that have already been published. Among the remaining cases, 6 concerned transgender men (age range 21-40 years) and 22 transgender women (age range 22-68 years). In transgender men all reported ADRs were cardiovascular events with pulmonary embolism in 50% of cases. Treatment with testosterone enanthate was involved in all subjects. Therapy was discontinued in 3 cases and total recovery was observed in 2 of them. In transgender women, antiandrogens, mainly cyproterone acetate (CPA), were involved in 68% of reported cases. Estrogens were implicated in 77% of cases, mostly in association with progestins or CPA. Cases of meningioma were the main ADRs observed, followed by cardiovascular ADRs such as ischaemic stroke or acute coronary syndrome. Two cases were related to self-induced drug intoxication. Gender affirming HT was completely discontinued in 14 transgender women and a total recovery was noted in 8 of them.

Conclusion

Our data show a previously unreported and non-negligible proportion of cases indicating cardiovascular ADRs in young transgender men treated with testosterone enanthate. In transgender women, meningioma was the most frequently reported ADRs followed by cardiovascular events. A continued vigilance and further research are necessary to identify risk factors that might lead to individualisation of treatment strategies. There is a necessity to increase the awareness and implement preventive and education measures.