title: Risk of hormonotherapy in transgender people: Literature review and data from the French Database of Pharmacovigilance.
abstract: OBJECTIVE
  After the diagnosis of transsexualism, hormone therapy is an established stage of gender identity disorder treatment for inducing secondary sex characteristic development of the target gender while reducing that of the birth sex. The aim of this study was to review existing data about the risk of hormone therapy in transsexual people.
  
  
  METHODS
  A PubMed search was done to identify relevant data about adverse drug reactions (ADRs) and mortality associated to hormones exposure. Furthermore, case reports of hormonal therapy-induced ADRs were identified in the French Pharmacovigilance DataBase (FPDB).
  
  
  RESULTS
  Review of currently available data showed an increase of thromboembolic effects and hyperprolactinemia with oestrogens. Both oestrogens and testosterone derivatives could induce hepatic effects. Currently, there is no significant association between hormone exposure and cancer or mortality in transsexual people. Five ADRs were found in FPDB, and two of them were related to misuse (voluntary overdose and prescription error).
  
  
  CONCLUSIONS
  Potential for under-reporting and under-identification in the FPDB of hormonal therapy-induced ADRs in transsexual people should be underlined. Technical improvement of the FPDB could facilitate further identification of reports concerning the risk associated with hormonal therapy in transsexual subjects.
authors.affiliation: Service de pharmacologie clinique, Centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, Inserm U1027, faculté de médecine, 37, allées Jules-Guesde, 31000 Toulouse, France.
authors.forename: Anne Laure
authors.initials: AL
authors.lastname: Bourgeois
authors.affiliation: Département de pharmacovigilance, Agence nationale de sécurité du médicament et des produits de Santé ANSM, 143/147, boulevard Anatole, 93285 Saint-Denis cedex, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Auriche
authors.affiliation: Service de pharmacologie clinique, Centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, Inserm U1027, faculté de médecine, 37, allées Jules-Guesde, 31000 Toulouse, France.
authors.forename: Aurore
authors.initials: A
authors.lastname: Palmaro
authors.affiliation: Service de pharmacologie clinique, Centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, Inserm U1027, faculté de médecine, 37, allées Jules-Guesde, 31000 Toulouse, France.
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Montastruc
authors.affiliation: Service de pharmacologie clinique, Centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, Inserm U1027, faculté de médecine, 37, allées Jules-Guesde, 31000 Toulouse, France. Electronic address: haleh.bagheri@univ-tlse3.fr.
authors.forename: Haleh
authors.initials: H
authors.lastname: Bagheri
mesh_terms: D000328:Adult; D056486:Chemical and Drug Induced Liver Injury; D016208:Databases, Factual; D004967:Estrogens / Q000009:adverse effects*; D005260:Female; D006801:Humans; D006966:Hyperprolactinemia / Q000139:chemically induced; D008297:Male; D060735:Pharmacovigilance; D012306:Risk; D057829:Gender-Affirming Procedures; D013739:Testosterone / Q000009:adverse effects*; D013923:Thromboembolism / Q000139:chemically induced; D063106:Transgender Persons; D014189:Transsexualism / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D004967:Estrogens; D013739:Testosterone
keywords: Adverse drug reactions; Hormone therapy; Hormonothérapie; Risque médicamenteux; Transsexual; Transsexuel