PMID- 37594595 OWN - NLM STAT- MEDLINE DCOM- 20231116 LR - 20231116 IS - 1433-2965 (Electronic) IS - 0937-941X (Linking) VI - 34 IP - 12 DP - 2023 Dec TI - A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS). PG - 2047-2058 LID - 10.1007/s00198-023-06877-6 [doi] AB - Abaloparatide (ABL) is a US Food and Drug Administration-approved parathyroid hormone-related peptide analog for treatment of osteoporosis in postmenopausal women at high risk of fracture. However, real-world data regarding its long-term safety and tolerability in large sample population are incomplete. We evaluated abaloparatide-associated safety signals by data mining of the FDA pharmacovigilance database. INTRODUCTION: We investigated 33,480(0.14%) ABL-related adverse events (AEs) through data mining of Food and Drug Administration Adverse Event Reporting System (FAERS) retrospectively. METHODS: Reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) were employed to quantify the signals of ABL-related AEs from 2017Quarter2 to 2022.Serious and non-serious cases were compared by Mann-Whitney U test or Chi-squared (chi(2)) test. RESULTS: We collected 8,470,497 reports from the FAERS database, including 11,487 reports defined ABL as the primary suspected (PS) drug. Additionally, 36.16% of the reports were submitted by healthcare professionals (n=4154), compared to 62.26% reported by consumers (n=7140). A total 99 signals simultaneously conforming to four algorithms were detected, among which, 35 signals were identified as unexpected signals. Such as growing pains (n=13), waist circumference increased (n=21), sensory disturbance (n=103), tinnitus (n=65), visual acuity reduced (n=54), blood alkaline phosphatase increased (n=61), and hair growth abnormal (n=13). Patient age (p < 0.001) might be associated with an increased risk of AEs severity. The most common timeframe for AE occurrence was 0-7 days. CONCLUSION: Our study provided a deeper and broader understanding of abaloparatide's safety profiles, which would help healthcare professionals to mitigate the risk of AEs in clinical practice, a low number of unexpected AEs supporting ongoing additional pharmacovigilance. CI - (c) 2023. International Osteoporosis Foundation and Bone Health and Osteoporosis Foundation. FAU - Shi, X AU - Shi X AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, Hubei Province, China. FAU - Cheng, Q AU - Cheng Q AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, Hubei Province, China. FAU - Zhao, Y-Z AU - Zhao YZ AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, Hubei Province, China. FAU - Zou, S-P AU - Zou SP AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, Hubei Province, China. FAU - Sun, M-H AU - Sun MH AUID- ORCID: 0000-0002-1556-543X AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, Hubei Province, China. Smh007tj@163.com. LA - eng PT - Journal Article DEP - 20230818 PL - England TA - Osteoporos Int JT - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JID - 9100105 RN - AVK0I6HY2U (abaloparatide) RN - 0 (Parathyroid Hormone-Related Protein) SB - IM MH - United States/epidemiology MH - Humans MH - Female MH - *Pharmacovigilance MH - *Parathyroid Hormone-Related Protein/adverse effects MH - Adverse Drug Reaction Reporting Systems MH - Retrospective Studies MH - Bayes Theorem OTO - NOTNLM OT - Abaloparatide OT - Adverse events OT - Data mining OT - FAERS OT - Osteoporosis OT - Pharmacovigilance EDAT- 2023/08/18 12:42 MHDA- 2023/11/16 06:44 CRDT- 2023/08/18 11:08 PHST- 2023/01/27 00:00 [received] PHST- 2023/08/01 00:00 [accepted] PHST- 2023/11/16 06:44 [medline] PHST- 2023/08/18 12:42 [pubmed] PHST- 2023/08/18 11:08 [entrez] AID - 10.1007/s00198-023-06877-6 [pii] AID - 10.1007/s00198-023-06877-6 [doi] PST - ppublish SO - Osteoporos Int. 2023 Dec;34(12):2047-2058. doi: 10.1007/s00198-023-06877-6. Epub 2023 Aug 18.