Evidence map›Paper›PMID 39065666›Full record

ArticlePharmaceuticals (Basel, Switzerland)2024

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

Marwan A Alrasheed, Khalid A Alamer, Mashael Albishi, Abdulrahman A Alsuhibani, Omar A Almohammed, Abdulrahman Alwhaibi, Abdullah N Almajed, Jeff J Guo

Abstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Marwan A AlrasheedDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia.ORCID 0000-0001-8504-3779
Khalid A AlamerPharmacy Practice Department, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University, Dammam 34221, Saudi Arabia.
Mashael AlbishiDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia.
Abdulrahman A AlsuhibaniDepartment of Pharmacy Practice, College of Pharmacy, Qassim University, Buraidah 51452, Saudi Arabia.ORCID 0000-0003-4852-1166
Omar A AlmohammedDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia.ORCID 0000-0002-3792-4106
Abdulrahman AlwhaibiDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia.ORCID 0000-0001-8519-3363
Abdullah N AlmajedPharmaceutical Care Division, King Faisal Specialist Hospital and Research Centre, MBC 11, P.O. Box 3354, Riyadh 11211, Saudi Arabia.
Jeff J GuoJames L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH 45267, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew 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.

methodsThis 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.

resultsThe 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.

conclusionsIxazomib, 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.

Indexed as

cancermultiple myelomapharmacovigilance

Identifiers

PMID39065666
PMCPMC11279559

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.