PreprintArticleVersion 1Preserved in Portico This version is not peer-reviewed
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
Version 1
: Received: 14 September 2023 / Approved: 15 September 2023 / Online: 15 September 2023 (07:09:15 CEST)
How to cite:
Cao, Z.; Cheng, J.; Chen, Z.; Lei, X.; Yang, L.; Zhan, M.; Chen, F.; Liu, T.; Liu, X.; Li, X. 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. Preprints2023, 2023091049. https://doi.org/10.20944/preprints202309.1049.v1
Cao, Z.; Cheng, J.; Chen, Z.; Lei, X.; Yang, L.; Zhan, M.; Chen, F.; Liu, T.; Liu, X.; Li, X. 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. Preprints 2023, 2023091049. https://doi.org/10.20944/preprints202309.1049.v1
Cao, Z.; Cheng, J.; Chen, Z.; Lei, X.; Yang, L.; Zhan, M.; Chen, F.; Liu, T.; Liu, X.; Li, X. 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. Preprints2023, 2023091049. https://doi.org/10.20944/preprints202309.1049.v1
APA Style
Cao, Z., Cheng, J., Chen, Z., Lei, X., Yang, L., Zhan, M., Chen, F., Liu, T., Liu, X., & Li, X. (2023). 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. Preprints. https://doi.org/10.20944/preprints202309.1049.v1
Chicago/Turabian Style
Cao, Z., Xiaoya Liu and Xuejuan Li. 2023 "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" Preprints. https://doi.org/10.20944/preprints202309.1049.v1
Abstract
Background: Although triptorelin acetate (TA) is generally considered a safe medication, severe adverse drug reactions (ADRs) to triptorelin have occurred. In this study, we present the largest retrospective analysis of ADRs related to TA during the treatment of pediatric central precocious puberty. Methods: We describe a total of 38 suspected cases of TA-induced ADRs reported to the pharma-covigilance center of Shenzhen Children’s Hospital from September 2015 to December 2022. Causality assessment was carried out using the validated Kramer’s algorithm. The severity of ADRs was evaluated using the Modified Hartwig and Siegel Scale. Results: The most common ADRs attributed to TA were damage to the cutaneous tissues (29.3%) and reactions affecting the systemic and digestive systems (20.7%). The majority (61.1%) of ADRs occurred within 2 hours of administration. Among the 12 patients with severe ADRs, the three most frequent symptoms were anaphylactic reactions, hip synovitis, and arthralgia. Additional-ly, six patients experienced ADRs due to a change in the manufacturing process. Conclusion: The majority of ADRs observed in pediatric cases were type I anaphylactic reactions, which are rare but life-threatening. It is advisable to perform skin prick tests and intradermal tests when switching pharmaceutical manufacturers.
Keywords
adverse drug reactions; anaphylactic reactions; arthralgia; hip synovitis; central precocious puberty
Subject
Medicine and Pharmacology, Medicine and Pharmacology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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