Objective: 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). Design: We requested all the individual case safety reports related to gender-affirming HT recorded in the FPVD before the 27th of May 2020. We excluded previously published cases and those for which gender-affirming hormone therapy was not the suspected drug. Results: A total of 28 reports of ADRs were identified. Six concerned transgender men (age range 21-40 years) and 22 transgender women (age range 22-68 years). In transgender men taking testosterone enanthate, all reported adverse effects were cardiovascular events with pulmonary embolism in 50% of cases. In transgender women, antiandrogens, mainly cyproterone acetate, were involved in 68% of cases. Estrogens were involved in 77% of cases, mostly in association with progestin or cyproterone acetate. Meningioma was the principal ADR, followed by cardiovascular events. Conclusions: Our data show a previously unreported and non-negligible proportion of cases indicating cardiovascular ADRs in transgender men younger than 40 years, taking testosterone enanthate. In transgender women, cardiovascular events were the second most frequently reported 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 and implement preventive and education measures.

Aims: Baclofen is widely used for spastic disorders, and most recently for addictive disorders. The first signals of baclofen abuse occurred in the last decade. This study aims to assess the motives, diversion sources and routes of administration associated with the non-medical use of baclofen and examine health problems related to the non-medical use of baclofen. Methods: Spontaneous reports of baclofen abuse reported to the addictovigilance center of East France were analyzed. A literature search was simultaneously conducted using PubMed®, Web of Sciences®, and Google Scholar® databases. Both searches were performed in February 2021 without a time limit. Results: Forty-six cases were analysed (33-from the literature review and 13-from addictovigilance base). Baclofen’s non-medical use mainly affected male subjects with addictive history, but cases of primary abuse in subjects without any substance abuse history were also observed. Euphoria search was the most common reason for misuse. Route of administration included oral, snorting and sublingual use. Physicians were a common source for misused baclofen, but cases involving illegal sources were also observed. Most of the patients misusing baclofen presented serious complications, mainly represented by neurological and respiratory disturbances. Physical and psychological dependence to baclofen was observed in three persons. Conclusion: Although baclofen abuse remains relatively infrequent or (most likely) underestimated, this study helped to confirm the intrinsic abuse potential of baclofen and make visible the baclofen-abuse-related health harms. Careful consideration and benefit-risk analysis should be employed when prescribing baclofen, and emergency departments should be aware of baclofen dangers in abuse situations.