Descriptive Analysis of Adverse Events Reported for New Multiple Myeloma Medications Using FDA Adverse Event Reporting System (FAERS) Databases from 2015 to 2022.

Autor: Alrasheed MA; Department of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia., Alamer KA; Pharmacy Practice Department, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam 34221, Saudi Arabia., Albishi M; Department of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia., Alsuhibani AA; Department of Pharmacy Practice, College of Pharmacy, Qassim University, Buraidah 51452, Saudi Arabia., Almohammed OA; Department of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia., Alwhaibi A; Department of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia., Almajed AN; Pharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, MBC 11, P.O. Box 3354, Riyadh 11211, Saudi Arabia., Guo JJ; James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH 45267, USA.
Jazyk: angličtina
Zdroj: Pharmaceuticals (Basel, Switzerland) [Pharmaceuticals (Basel)] 2024 Jun 21; Vol. 17 (7). Date of Electronic Publication: 2024 Jun 21.
DOI: 10.3390/ph17070815
Abstrakt: Background: New multiple myeloma (MM) medications have revolutionized the treatment landscape, but they are also associated with a range of adverse events (AEs). This study aims to provide a comprehensive overview of AEs reported for four new MM medications: daratumumab, ixazomib, elotuzumab, and panobinostat.
Methods: This study uses a descriptive retrospective approach to analyze the FDA Adverse Event Reporting System (FAERS) from 2015 to 2022. It includes variables like medication names, report details, patient demographics, adverse events, and reporter types. The initial dataset consists of over 3700 adverse events, which are categorized into 21 groups for clarity and comparison.
Results: The FAERS database revealed 367,756 adverse events (AEs) associated with novel multiple myeloma drugs from 2015-2022. Ixazomib had the highest number of reported AEs with 206,243 reports, followed by daratumumab with 98,872 reports, then elotuzumab with 26,193 AEs. Ixazomib's AE reports increased dramatically over the study period, rising approximately 51-fold from 1183 in 2015 to 60,835 in 2022. Of the medications studied, ixazomib also recorded the highest number of deaths (24,206), followed by daratumumab (11,624), panobinostat (7227), and elotuzumab (3349). The majority of AEs occurred in patients aged 55-64 and 65-74 years.
Conclusions: Ixazomib, a new MM medication, had the highest number of AEs reported. Also, it has the highest rate of reported deaths compared to other new MM medications. Clinicians should be aware of the potential AEs associated with this medication and further research is needed to understand the reasons for the high number of AEs and to develop mitigation strategies. More attention should also be paid to the safety of new multiple myeloma medications in younger patients.
Databáze: MEDLINE
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