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Novantrone FDA Alerts

The FDA Alert(s) below may be specifically about Novantrone or relate to a group or class of drugs which include Novantrone (mitoxantrone).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for mitoxantrone

Mitoxantrone Hydrochloride (marketed as Novantrone and generics)

Jul 29, 2008

Audience: Neurological and Oncological healthcare professionals, risk managers

[Posted 07/29/2008] FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug.

These recommendations were established in 2005 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 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.

[July 29, 2008 - Information for Healthcare Professionals - FDA]

Novantrone (mitoxantrone for injection concentrate)

May 24, 2005

Audience: Neurologists, oncologists, cardiologists, and consumers

Serono and FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Novantrone [mitoxantrone], indicated for treatment of multiple sclerosis (MS). The Dear Healthcare Professional letter provides additional information concerning the risks of cardiotoxicity associated with Novantrone and also provides supplemental information regarding secondary acute myelogenous leukemia (AML) reported in MS patients treated with Novantrone.

[April, 2005 - Dear Healthcare Professional Letter - Serono]
[March, 2005 - Label - Serono]
[March, 2005 - Patient Information - Serono]

More Novantrone Resources