In this article, we point out a few of the medical news reports about heart-related Imbruvica side effects that have been published in the past 12 months.
First, there is this November 2020 Healio article, “Link between ibrutinib-related hypertension, heart problems necessitates close monitoring”, which provides some key findings from several different medical journal articles about research focused on heart-related Imbruvica side effects. From the Conclusions part of that Healio article:
[Chronic lymphocytic leukemia (CLL)] is a disease of the elderly. Real-world evaluations suggest many patients initiated on [Imbruvica (ibrutinib)] have significant comorbidities, many of them cardiovascular.Hypertension — an important risk factor for the development of atrial fibrillation — may occur at a much higher rate in real-world practice settings than reported in clinical trials.
Patients should be monitored for the development of new or worsened hypertension, particularly early in the therapy course.
Second, we have a June 2021 report from ThePharmaLetter, “Imbruvica: new safety signal for use with rituximab and ACE inhibitors” about the European Medicines Agency (EMA) issuing a new safety signal for Imbruvica with rituximab:
As part of its advice on safety-related aspects to other European Medicines Agency committees, the Pharmacovigilance Risk Assessment Committee (PRAC) last week discussed a direct healthcare professional communication (DHPC) containing important safety information for Imbruvica (ibrutinib).
This DHPC aims to inform healthcare professionals about a new safety signal of sudden or cardiac death with Imbruvica when used in combination with rituximab and angiotensin-converting enzyme (ACE) inhibitors. The signal was recognized following a review of the findings of a clinical trial….
Third, and most recent, is a September 2021 MedPage Today news report, “Ibrutinib for CLL Tied to Higher Heart Risks vs Chemotherapy”, about there being increased risks for atrial fibrillation, bleeding, and heart failure seen in a Canadian cohort of patients using Imbruvica:
Use of the Bruton tyrosine kinase (BTK) inhibitor ibrutinib (Imbruvica) was linked with cardiovascular risks in patients with chronic lymphocytic leukemia (CLL), according to results of a population-based cohort study.
Over 3 years, the incidence of atrial fibrillation (AF)-related healthcare contact was 22.7% in patients treated with [Imbruvica (ibrutinib)] compared with 11.7% in patients who received chemotherapy, risk of hospital-diagnosed bleeding was 8.8% and 3.1%, respectively, and risk of heart failure (HF) was 7.7% and 3.6%, reported Husam Abdel-Qadir, MD, PhD, of Women’s College Hospital in Toronto, and colleagues.
We will continue to monitor the medical literature for more reports of heart-related Imbruvica side effects, as well as watch for possible regulatory action by the FDA or the EMA.
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