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.
Cao. Zhongqiang Z; Cheng. Junjie J; Chen. Zebin Z; Lei. Xi X; Yang. Ling L; Zhan. Min M; Chen. Fangzhao F; Liu. Ting T; Liu. Xiaoya X; Li. Xuejuan X
Key Findings
- 29.3% of reactions were skin damage, 20.7% affected systemic/digestive systems
- 61.1% of adverse events occurred within 2 hours of injection
- Severe cases (anaphylaxis, hip synovitis, arthralgia) were often tied to a manufacturing change
Practical Outcomes
- If you’re using triptorelin off‑label, be aware that rapid, severe allergic reactions can happen, especially after a brand switch. Do skin prick or intradermal testing before changing manufacturers, and monitor closely for any reaction within the first two hours after dosing.
Summary
The study looked at 38 kids who got triptorelin and had bad reactions, mainly skin problems and serious allergic reactions that happened quickly after the shot. Some severe cases were linked to a change in how the drug was made, showing that even small manufacturing tweaks can cause trouble. The authors suggest testing skin reactions before switching brands to avoid life‑threatening allergies.
Abstract
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. We describe a total of 38 suspected cases of TA-induced ADRs reported to the pharmacovigilance 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. 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 h of administration. Among the 12 patients with severe ADRs, the three most frequent symptoms were anaphylactic reactions, hip synovitis, and arthralgia. Additionally, six patients experienced ADRs due to a change in the manufacturing process. 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.
Study Information
pubmed
2025
2025-12-03T00:00:00.000Z
10.1186/s12887-025-06293-1
17