PMID- 38245664 OWN - NLM STAT- MEDLINE DCOM- 20240325 LR - 20240325 IS - 2210-7711 (Electronic) VI - 46 IP - 2 DP - 2024 Apr TI - Data mining and analysis of adverse event signals associated with teprotumumab using the Food and Drug Administration adverse event reporting system database. PG - 471-479 LID - 10.1007/s11096-023-01676-9 [doi] AB - BACKGROUND: Teprotumumab was approved by the US Food and Drug Administration (FDA) for the treatment of thyroid eye disease in 2020. However, its adverse events (AEs) have not been investigated in real-world settings. AIM: This study aimed to detect and evaluate AEs associated with teprotumumab in the real-world setting by conducting a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database. METHOD: Reporting odds ratio (ROR) was used to detect risk signals from the data from January 2020 to March 2023 in the FAERS database. RESULTS: A total of 3,707,269 cases were retrieved, of which 1542 were related to teprotumumab. The FAERS analysis identified 99 teprotumumab-related AE signals in 14 System Organ Classes (SOCs). The most frequent AEs were muscle spasms (n = 287), fatigue (n = 174), blood glucose increase (n = 121), alopecia (n = 120), nausea (n = 118), hyperacusis (n = 117), and headache (n = 117). The AEs with strongest signal strengths were autophony (ROR = 14,475.49), deafness permanent (ROR = 1853.35), gingival recession (ROR = 190.74), deafness neurosensory (ROR = 129.89), nail growth abnormal (ROR = 103.67), onychoclasis (ROR = 73.58), ear discomfort (ROR = 72.88), and deafness bilateral (ROR = 62.46). Eleven positive AE signals were found at the standardized MedDRA queries (SMQs) level, of which the top five SMQs were hyperglycemia/new-onset diabetes mellitus, hearing impairment, gastrointestinal nonspecific symptoms and therapeutic procedures, noninfectious diarrhea, and hypertension. Age significantly increased the risk of hearing impairment. CONCLUSION: This study identified potential new and unexpected AE signals of teprotumumab. Our findings emphasize the importance of pharmacovigilance analysis in the real world to identify and manage AEs effectively, ultimately improving patient safety during teprotumumab treatment. CI - (c) 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG. FAU - Zhang, Sha AU - Zhang S AD - Department of Pharmacy, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China. FAU - Wang, Yidong AU - Wang Y AD - Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. FAU - Qi, Zhan AU - Qi Z AD - Department of Pharmacy, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China. FAU - Tong, Shanshan AU - Tong S AD - Department of Pharmacy, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China. FAU - Zhu, Deqiu AU - Zhu D AD - Department of Pharmacy, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China. zdq_0726@163.com. LA - eng PT - Journal Article DEP - 20240120 PL - Netherlands TA - Int J Clin Pharm JT - International journal of clinical pharmacy JID - 101554912 RN - Y64GQ0KC0A (teprotumumab) RN - 0 (Antibodies, Monoclonal, Humanized) SB - IM MH - United States/epidemiology MH - Humans MH - United States Food and Drug Administration MH - *Drug-Related Side Effects and Adverse Reactions/epidemiology MH - Data Mining MH - Pharmacovigilance MH - Adverse Drug Reaction Reporting Systems MH - *Hearing Loss MH - *Antibodies, Monoclonal, Humanized OTO - NOTNLM OT - Adverse events OT - Data mining OT - FAERS OT - Pharmacovigilance OT - Teprotumumab EDAT- 2024/01/21 00:42 MHDA- 2024/03/25 06:44 CRDT- 2024/01/20 23:24 PHST- 2023/10/07 00:00 [received] PHST- 2023/11/20 00:00 [accepted] PHST- 2024/03/25 06:44 [medline] PHST- 2024/01/21 00:42 [pubmed] PHST- 2024/01/20 23:24 [entrez] AID - 10.1007/s11096-023-01676-9 [pii] AID - 10.1007/s11096-023-01676-9 [doi] PST - ppublish SO - Int J Clin Pharm. 2024 Apr;46(2):471-479. doi: 10.1007/s11096-023-01676-9. Epub 2024 Jan 20.