Adverse effects of gender-affirming hormonal therapy in transgender persons: Assessing reports in the French pharmacovigilance database.

Limited data are available on adverse drug reactions (ADRs) of gender-affirming hormone therapy (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. In this nationwide retrospective study, we aimed to analyze ADRs related to gender-affirming HT reported in the French pharmacovigilance database (FPVD). We requested all the individual case safety reports related to gender-affirming HT recorded in the FPVD before May 27, 2020. We excluded previously published cases and those where gender-affirming HT was not the suspected drug. A total of 28 reports of ADRs were identified. Six concerned transgender men (21-40 years) and 22 transgender women (22-68 years). In transgender men taking testosterone enanthate, all reported ADRs were cardiovascular events, with pulmonary embolism in 50% of cases. Median time to onset (TTO) was 34 months. In transgender women, antiandrogens, mainly cyproterone acetate, were involved in 68% of cases, and estrogens in 77% of cases, mostly in association with progestin or cyproterone acetate. Meningiomas were the principal ADRs, followed by cardiovascular events, with a median TTO of 5.3 months. Our data show a previously unreported, non-negligible proportion of cases indicating cardiovascular ADRs in transgender men younger than 40 years. In transgender women, cardiovascular events were the second most frequent ADR. Further research is necessary to identify risk factors that might help to the individualization of treatment strategies. There is a necessity to increase awareness, implement preventive and education measures.

Endovascular Treatment of Atherosclerotic Iliac Stenosis: Local and Systemic Complications of the Open Brachial Access.

BACKGROUND: The femoral access is the approach of reference for iliac angioplasty. In the current context of an early ambulation and a minimization of in-hospital stay period, the brachial access seems to be an appropriate approach, especially that long and small diameter equipments are available. Furthermore, it is extremely useful in case of inappropriate or unavailable femoral access. The aim of this study was to evaluate the complication risk factors of the brachial approach in the treatment of iliac stenosis. METHODS: Between January 2012 and December 2013, we performed 281 iliac transluminal angioplasties of which 57 (20%) consecutive left brachial artery accesses were performed in 54 patients. The choice of brachial access was justified in 68% of the cases by an unavailable femoral access, in 29% of the cases by the presence of bilateral iliac lesions, and in 3% of the cases after failure of retrograde femoral approach. RESULTS: The patients were of a male majority (81%) with a mean age of 66 ± 9 years. The procedure was performed under local anesthesia in 65% of the cases. No upper limb ischemia or nervous complications had been reported. No cerebrovascular stroke has been identified. One patient presented with dysarthria associated with disorientation without the presence of cerebrovascular ischemia on the computed tomography scan and on the magnetic resonance imaging. There were 3 major hematomas at the brachial access site, which required reoperation; these 3 patients were on dialysis. There was no statistically significant relationship between a complication occurrence and the diameter or length of the introducer. The mean in-hospital stay period was 2 days. The procedure was considered successful in 91% of the cases. We reported 5 cases of failure: 4 of which was due to a difficulty in crossing the lesion and 1 due to a very short material. The only significant risk factor of failure was the thrombosis of the iliac axis (odds ratio 23.3, 95% confidence interval 2.5-264.6, P = 0.003). CONCLUSIONS: The femoral access remains the recommended approach for the treatment of iliac occlusive lesions. However, brachial artery access seems to provide a safe and secure alternative approach for patients when femoral artery access is unavailable. It allows a rapid ambulation and an ambulatory care.