Cardiovascular Adverse Drug Reactions Often Occurred Soon After Administration Of Imbruvica, According To Recent Medical Study
(Posted by Tom Lamb at DrugInjuryWatch.com)
Patients treated with Imbruvica (ibrutinib) had an increased occurrence of severe and sometimes fatal cardiac events, with Imbruvica cardiovascular toxicities suspected in these higher serious side effects rates, according to a recent clinical trial where Imbruvica therapy was compared with conventional chemotherapy.
This medical journal article, "Cardiovascular Toxicities Associated With Ibrutinib", reports the findings of this medical study that assessed cardiovascular adverse drug reactions (CV-ADR) associated with Imbruvica. It was published in the Journal of the American College of Cardiology, Volume 74, Issue 13, October 2019.
From the Abstract for this article we get the following information:
- Background: [Imbruvica (ibrutinib)] has revolutionized treatment for several B-cell malignancies. However, a recent clinical trial where [Imbruvica (ibrutinib)] was used in a front-line setting showed increased mortality during treatment compared with conventional chemotherapy. Cardiovascular toxicities were suspected as the culprit but not directly assessed in the study.
- Results: This study identified 303 [Imbruvica (ibrutinib)]-associated cardiovascular deaths. [Imbruvica (ibrutinib)] was associated with higher reporting of supraventricular arrhythmias (SVAs) (ROR: 23.1; 95% confidence interval: 21.6 to 24.7; p < 0.0001; IC025: 3.97), central nervous system (CNS) hemorrhagic events (ROR: 3.7; 95% confidence interval: 3.4 to 4.1; p < 0.0001; IC025: 1.63), heart failure (ROR: 3.5; 95% confidence interval: 3.1 to 3.8; p < 0.0001; IC025: 1.46), ventricular arrhythmias (ROR: 4.7; 95% confidence interval: 3.7 to 5.9; p < 0.0001; IC025: 0.96), conduction disorders (ROR: 3.5; 95% confidence interval: 2.7 to 4.6; p < 0.0001; IC025: 0.76), CNS ischemic events (ROR: 2.2; 95% confidence interval: 2.0 to 2.5; p < 0.0001; IC025: 0.73), and hypertension (ROR: 1.7; 95% confidence interval: 1.5 to 1.9; p < 0.0001; IC025: 0.4). CV-ADR often occurred early after [Imbruvica (ibrutinib)] administration. Importantly, CV-ADR were associated with fatalities that ranged from ∼10% (SVAs and ventricular arrhythmias) to ∼20% (CNS events, heart failure, and conduction disorders). [Imbruvica (ibrutinib)]-associated SVA portends poor prognosis when CNS events occur concomitantly, with 28.8% deaths (15 of 52 cases). [emphasis added]
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Based on that data, the medical researchers who did this study concluded:
- Severe and occasionally fatal cardiac events occur in patients exposed to Imbruvica; and,
- These events, with Imbruvica cardiovascular toxicities suspected, should be considered by doctors involved with patient care and by researchers designing future clinical trials.
Imbruvica received initial FDA approval in 2013. There were several changes made to the Warnings and Precautions section of the Prescribing Information for Imbruvica in July 2019, some of which addressed Imbruvica cardiovascular toxicities discussed in the recent medical study article.
We will continue to monitor the drug safety profile of Imbruvica and report significant developments, including any additional Imbruvica drug label changes, here.
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