FDA is reemphasizing the importance of avoiding cardiotoxicity with mitoxantrone (novantrone)

FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis (MS).

Congestive heart failure can occur while a patient is being treated with mitoxantrone, or even months or years after therapy is stopped. The risk of cardiotoxicity increases as the cumulative dose increases.

In 2005, the product labeling was updated to recommend that MS patients have their left ventricular ejection fraction (LVEF) checked before each dose of mitozantrone, in addition to having a baseline measurement before starting treatment. Since that time, a postmarketing safety study has shown that quantitative LVEF monitoring was not being performed in a majority of MS patients treated with the drug.

Given the possibility of severe cardiotoxicity, FDA is reminding healthcare professionals about the importance of cardiac monitoring of MS patients during treatment with mitoxantrone. Also, FDA is now advising that all MS patients who have finished mitoxantrone receive yearly quantitative LVEF evaluation to detect late-occurring cardiac toxicity.

Additional Information:

FDA MedWatch Safety Alert. Mitoxantrone Hydrochloride (marketed as Novantrone and generics). July 29, 2008

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mitoxantrone