Evaluation of Potential Adverse Effects of Gender-Affirming Hormonal Therapy; Findings from the Spanish Pharmacovigilance System Database.

A total of 21 reports of suspected adverse drug reactions (ADRs) from gender-affirming hormone therapy (GAHT) were identified in the Spanish Pharmacovigilance System database.

• 13 reports corresponded to masculinizing therapy with testosterone
• 8 reports corresponded to feminizing therapy with estradiol and cyproterone acetate
• Reports were obtained by consulting the Andalusian Centre for Pharmacovigilance (CAFV) using three search algorithms to select reports derived from hormone therapy used by transgender people

Most of the reported adverse drug reactions were of non-serious symptoms.

• Skin and subcutaneous tissue disorders were among the most common suspected ADRs
• Neoplasms were also among the most common suspected ADRs
• Psychiatric, vascular, gastrointestinal, and nervous system disorders were also frequently reported

The median age of patients differed between those receiving masculinizing versus feminizing therapy.

• The median age was 23.6 years for those receiving masculinizing therapy
• The median age was 27 years for those receiving feminizing therapy

The Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H) was used as the data source for evaluating adverse reactions suspected to be due to gender-affirming hormone therapy.

• Three search algorithms were used to select only those reports derived from hormone therapy used by transgender people
• The Andalusian Centre for Pharmacovigilance (CAFV) database was consulted
• Masculinizing therapy involved testosterone, while feminizing therapy involved estradiol and cyproterone acetate

The authors identified a gap in evidence-based treatment guidelines for transgender people undergoing hormone therapy.

• The data highlight the need for well-designed studies specifically focused on transgender people undergoing hormone therapy
• Such studies are described as essential to develop evidence-based treatment guidelines tailored to this population
• The authors call for accurate, population-specific information about potential health risks associated with gender-affirming hormone use