| アブストラクト | OBJECTIVE: Propranolol, a non-selective beta-adrenergic receptor blocker, is the first FDA-approved orphan drug for the treatment of infantile hemangioma (IH). While it has demonstrated substantial therapeutic benefits, the safety profile of propranolol in infants remains insufficiently characterized, particularly in real-world settings. METHODS: A retrospective pharmacovigilance analysis of FAERS reports from Q1 2015 to Q4 2024 was conducted, applying four signal detection algorithms (ROR, PRR, BCPNN, MGPS) to identify disproportional AE signals related to propranolol in IH. RESULTS: A total of 1615 AE reports were included. Signal detection identified events across 20 System Organ Classes (SOCs), with vascular, psychiatric, and metabolism and nutrition disorders being most prominent. At the Preferred Term (PT) level, the most frequently reported AEs were sleep disorder (n = 149, ROR = 32.67), peripheral coldness (n = 87, ROR = 108.73), and hypoglycaemia (n = 62, ROR = 22.95), which were pharmacologically plausible and clinically relevant. CONCLUSIONS: This study identified safety signals associated with propranolol in infants with IH, highlighting risks across organ systems. These findings support the need for vigilant monitoring, individualized risk assessment, and refinement of labeling recommendations to optimize safety in this vulnerable population. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13023-026-04331-4. |
|---|
| ジャーナル名 | Orphanet journal of rare diseases |
|---|
| Pubmed追加日 | 2026/4/2 |
|---|
| 投稿者 | Li, Xuanjia; Zhao, Xingyu; Yang, Chengzhe; Chen, Anwei |
|---|
| 組織名 | Department of Plastic, Aesthetic, and Burn Surgery, Qilu Hospital of Shandong;University, Jinan, Shandong, 250012, China.;Department of Oral and Maxillofacial Surgery, Qilu Hospital of Shandong;University, Jinan, Shandong, 250012, China. yangchengzhe@email.sdu.edu.cn.;University, Jinan, Shandong, 250012, China. Dr.anwei-chen@sdu.edu.cn. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41923118/ |
|---|
