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FDA recommendations for cardiac monitoring of patients with multiple sclerosis (MS) who are treated with Novantrone

Posted Jan 14 2009 8:24pm
Information contributed by Cherie C. Binns RN BS MSCN
Medscape Medical News

Medscape Alerts

Additional Cardiac Monitoring for Patients on Mitoxantrone - from Heartwire
— a professional news service of WebMD


Sue Hughes


July 30, 2008 — The FDA has issued an alert informing healthcare professionals about additional recommendations for cardiac monitoring of patients with multiple sclerosis (MS) who are treated with mitoxantrone (marketed as Novantrone and as generics) [1].

In 2005, the labeling for mitoxantrone was changed to recommend that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and before administering each dose of mitoxantrone to patients with MS. These changes were established in response to 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 mitoxantrone that were lower than 100 mg/m2.

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