FDA ALERT [7/29/2008]: FDA is informing health care professionals about additional recommendations for cardiac monitoring and reminding of the importance of monitoring cardiac function in patients with multiple sclerosis (MS) who are treated with mitoxantrone.

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. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS.

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.

This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this document when additional information or analyses become available.