Federal regulators have informed healthcare providers of new heart monitoring recommendations or patients being treated with Novantrone. Novantrone and generic equivalents are approved to treat multiple sclerosis (MS) and cancer. Novantrone has been linked to the development of congestive heart failure. In 2005, the labeling for Novantrone (known generically as mitoxantrone) was changed to recommend […]
Federal regulators have informed healthcare providers of new heart monitoring recommendations or patients being treated with <"https://www.yourlawyer.com/topics/overview/novantrone">Novantrone. Novantrone and generic equivalents are approved to treat multiple sclerosis (MS) and cancer. Novantrone has been linked to the development of congestive heart failure.
In 2005, the labeling for Novantrone (known generically as mitoxantrone) was changed to recommend that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and before administering each dose of Novantrone to patients with MS. The 2005 label change was initiated after postmarketing and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of Novantrone that were lower than 100 mg/m2. LVEF measures the amount of blood pumped out per beat by the heart’s left ventricle.
Recently, the Food & Drug Administration (FDA) received information from a postmarketing safety study that demonstrated poor adherence to the monitoring recommendations made in 2005 in clinical practice. This study used insurance-claims data and medical-record reviews to examine cardiac monitoring patterns in clinical practice. In this study, it was noted that four patients developed congestive heart failure 4 to 17 months after completing therapy with Novantrone.
The FDA is now working with the manufacturers of Novantrone to remind healthcare professionals of the importance of adhering to the recommendations for patients with MS who are treated with Novantrone and generic equivalents.
The FDA and the manufacturers are now advising that all patients with MS who have finished treatment with mitoxantrone receive yearly quantitative LVEF evaluations to detect late-occurring cardiac toxicity.
The FDA has issued the following recommendations for patients treated with mitoxantrone.
For all patients
For patients with MS
For patients with cancer