PMID- 37950855 OWN - NLM STAT- MEDLINE DCOM- 20240122 LR - 20240202 IS - 1096-8652 (Electronic) IS - 0361-8609 (Linking) VI - 99 IP - 2 DP - 2024 Feb TI - Comparative pharmacovigilance assessment of adverse events associated with the use of hydroxyurea, L-glutamine, voxelotor, and crizanlizumab in sickle cell disease. PG - E37-E41 LID - 10.1002/ajh.27153 [doi] AB - Using disproportionality analysis, this study compared the adverse events (AEs) associated with the use of the new agents (e.g., L-glutamine, voxelotor, and crizanlizumab) to the commonly used medication, hydroxyurea, in sickle cell disease. We found that the most frequent drug-related AEs observed in this real-world study were consistent with those in the HOPE (voxelotor) and SUSTAIN (crizanlizumab) trials, but the rates of AEs were lower. Our study demonstrates that the most common AEs and symptoms of an increased risk associated with the individual drugs varied by treatment. Disproportionate reporting signals of drug-related AEs may also capture information that is independent of subjective measures of patient-reported symptoms. Our study highlights the important need for facilitating patient-physician communication in routine clinical care to understand patient-reported symptoms. CI - (c) 2023 Wiley Periodicals LLC. FAU - Chen, Ming AU - Chen M AUID- ORCID: 0000-0003-3215-8657 AD - Institute of Health Outcomes and Policy, University of Tennessee Health Science Center, Memphis, Tennessee, USA. AD - Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, Tennessee, USA. FAU - Hankins, Jane S AU - Hankins JS AUID- ORCID: 0000-0003-4439-7321 AD - Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee, USA. AD - Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA. AD - Center for Sickle Cell Disease, University of Tennessee Health Science Center, Memphis, Tennessee, USA. FAU - Zhang, Min AU - Zhang M AD - Vanke School of Public Health, Tsinghua University, Beijing, China. FAU - Ataga, Kenneth I AU - Ataga KI AUID- ORCID: 0000-0002-4501-9982 AD - Center for Sickle Cell Disease, University of Tennessee Health Science Center, Memphis, Tennessee, USA. AD - Department of Medicine - Hematology, University of Tennessee Health Science Center, Memphis, Tennessee, USA. LA - eng PT - Letter DEP - 20231111 PL - United States TA - Am J Hematol JT - American journal of hematology JID - 7610369 RN - X6Q56QN5QC (Hydroxyurea) RN - L7451S9126 (crizanlizumab) RN - 3ZO554A4Q8 (voxelotor) RN - 0RH81L854J (Glutamine) RN - 0 (Benzaldehydes) RN - 0 (Pyrazines) RN - 0 (Pyrazoles) RN - 0 (Antibodies, Monoclonal, Humanized) SB - IM MH - Humans MH - *Hydroxyurea/adverse effects MH - Glutamine MH - Pharmacovigilance MH - *Anemia, Sickle Cell/drug therapy/complications MH - *Benzaldehydes MH - *Pyrazines MH - *Pyrazoles MH - *Antibodies, Monoclonal, Humanized EDAT- 2023/11/11 20:54 MHDA- 2024/01/22 06:43 CRDT- 2023/11/11 12:12 PHST- 2023/10/24 00:00 [revised] PHST- 2023/09/18 00:00 [received] PHST- 2023/10/25 00:00 [accepted] PHST- 2024/01/22 06:43 [medline] PHST- 2023/11/11 20:54 [pubmed] PHST- 2023/11/11 12:12 [entrez] AID - 10.1002/ajh.27153 [doi] PST - ppublish SO - Am J Hematol. 2024 Feb;99(2):E37-E41. doi: 10.1002/ajh.27153. Epub 2023 Nov 11.