Evaluation of Hypersensitivity Reactions with Leuprolide Acetate and Triptorelin Acetate in Children

Abstract

Introduction: Gonadotropin releasing hormone analogues (GnRHa) are commonly used to treat central precocious puberty (CPP). Generally, they are well-tolerated; however adverse reactions have been reported. Local adverse events occur in 10-15% of the patients who were treated with GnRHa. Anaphylactoid reactions with GnRHa are very rarely seen. The aim of this study is to report our clinical experience with hypersensitivity reactions seen in pediatric patients receiving leuprolide acetate (LA) and triptorelin acetate (TA) in CPP at the single pediatric tertiary medical center and to evaluate the incidence rate of hypersensitivity reactions. Methods: This retrospective study included children with CPP who were treated with GnRHa (LA and TA) at our hospital between January 2013 and December 2020. We analyzed clinical characteristics of patients who experienced adverse reactions and analyzed the incidence rate. Results: Seven side effects (adverse reactions) (0.69%) were observed among total of 1010 CPP patients who were treated with TA and LA. Sterile abscesses were observed in 3 patients (0.29%). None of the patients had an anaphylaxis. Tremors of both hands, a vomiting episode, an urticarial rash, and musculoskeletal stiffness were observed in one patient each. Conclusion: In our study, mild reactions were seen in 7 patients. GnRHa can be safely used and well-tolerated medications; but exceedingly rare, severe reactions can be developed.

A Retrospective Analysis of Spontaneous Reports of Suspected Adverse Drug Reactions to Triptorelin Acetate in a Tertiary Pediatric Medical Center: Still a Lot of Preventable Harm

“…Central precocious puberty is a rare condition in childhood, occurring in approximately 1 in every 5000 to 1 in every 10,000 individuals, and results from the early maturation of the hypothalamic-pituitary-gonadal (HPG) axis 1,2 . Diagnosis of central precocious puberty (CPP) is typically made when secondary sexual characteristics appear before the age of 8 in females and before the age of 9 in males.…”

“…These analogs work by suppressing gonadotropin and sex hormone secretion, thereby preventing the progression of advanced puberty and mitigating the impact on final adult height due to accelerated growth plate fusion 5 . One commonly used GnRH analog is triptorelin acetate (TA), a synthetic nanopeptide that downregulates GnRH receptors in the pituitary 2 . Although the majority of patients tolerate TA well, occasional adverse reactions do occur.…”