Cardiac Monitoring For Patients On Novantrone

FDA Warns of Need for On-Going Monitoring

The FDA is advising physicians who care for patients with Multiple Sclerosis (MS) and who are taking mitoxantrone, also known as Novantrone, or generics, of the need to undergo cardiac function monitoring not only while they are on the drug, but also every year once they've come off the drug.

In a news release sent out July 29, the FDA stated "In addition to adherence to the recommendations made in 2005, FDA and the manufacturers of mitoxantrone are now advising that all patients with MS who have finished treatment with mitoxantrone receive yearly quantitative LVEF evaluation to detect late-occurring cardiac toxicity."

In March 2005, the labeling for mitoxantrone was changed to recommend that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone to patients with MS. These changes were established in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with multiple sclerosis (MS) who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2.

Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice.

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Last updated on Apr-7-10