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Cardiovascular Complications of Modern Multiple Myeloma Therapy: A Pharmacovigilance Study
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  • Zaki Al-yafeai,
  • Mohamed Ghoweba,
  • Anil Ananthaneni,
  • Hamzah Abduljabar,
  • David Aziz
Zaki Al-yafeai
LSU Health Shreveport

Corresponding Author:[email protected]

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Mohamed Ghoweba
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Anil Ananthaneni
Louisiana State University Health Sciences Center Shreveport
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Hamzah Abduljabar
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David Aziz
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Background: Multiple myeloma accounts for over 15% of hematological malignancies. In attempt to tackle this malady, the FDA approved four drugs in 2015 which has propagated further development of new anti-multiple myeloma since. However, the health safety of these new agents is still ill-defined. The aim of this study is to delineate the cardiovascular adverse events of these drugs. Methods: We searched the cardiac adverse events of the newly approved FDA drugs since 2015 using the U.S. Food and Drug Administration Adverse Events Reporting System database (FAERS). We calculated the reporting odds ratio (ROR) with 95% confidence for four drugs that have the highest incidence of cardiovascular adverse events. Results: Among the medications that have approved for MM Between 2015-2020, four novel drugs showed the highest incidence of cardiotoxicity. ROR (95% CI) for atrial fibrillation due to elotuzumab, Ixazomib, daratumumab, and panobinostat compared to other FAERS drugs was 5.8 (4.4-7.7), 1.9 (1.5-2.3), 4.8 (4.2-5.6), and 5.7 (4.1-8.1), respectively. The ROR (95% CI) for cardiac failure was 8.2 (6.4-10.5), 4.7 (4.1-5.4), 5.8 (4.9-6.7), and 5.6 (3.8-8.1) and ROR (95% CI) for coronary disease was 2.7 (1.9-3.9), 2.7 (2.3-3.2), 2.3 (1.9-2.8), and 4.6 (3.2-6.6) due to elotuzumab, Ixazomib, daratumumab, and panobinostat versus all other drugs in FAERS. Conclusions: Our results demonstrated that the newly approved antimyeloma therapy (elotuzumab, Ixazomib, daratumumab, panobinostat) are significantly associated previously unknow cardiotoxicity. These results warrant further studies and highlight the importance of considering the cardiac history of patients with multiple myeloma when utilizing these novel agents.
28 May 2022Submitted to British Journal of Clinical Pharmacology
28 May 2022Submission Checks Completed
28 May 2022Assigned to Editor
30 May 2022Reviewer(s) Assigned
11 Jun 2022Review(s) Completed, Editorial Evaluation Pending
01 Jul 2022Editorial Decision: Revise Major
12 Jul 20221st Revision Received
12 Jul 2022Assigned to Editor
12 Jul 2022Submission Checks Completed
12 Jul 2022Review(s) Completed, Editorial Evaluation Pending
21 Jul 2022Editorial Decision: Revise Minor
27 Jul 20222nd Revision Received
27 Jul 2022Submission Checks Completed
27 Jul 2022Assigned to Editor
27 Jul 2022Review(s) Completed, Editorial Evaluation Pending
28 Jul 2022Editorial Decision: Revise Minor
29 Jul 20223rd Revision Received
29 Jul 2022Submission Checks Completed
29 Jul 2022Assigned to Editor
29 Jul 2022Review(s) Completed, Editorial Evaluation Pending
08 Aug 2022Editorial Decision: Accept
09 Sep 2022Published in British Journal of Clinical Pharmacology. 10.1111/bcp.15499