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FDA Issues New Warning for Novantrone

Jul 30, 2008 | Parker Waichman LLP Federal regulators have informed healthcare providers of new heart monitoring recommendations or patients being treated with Novantrone.  Novantrone and generic equivalents are approved to treat multiple sclerosis (MS) and cancer. Novantrone has been linked to the development of congestive heart failure.

In 2005, the labeling for Novantrone (known generically as mitoxantrone) was changed to recommend that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and before administering each dose of Novantrone to patients with MS. The 2005 label change was initiated after 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 Novantrone that were lower than 100 mg/m2.  LVEF measures the amount of blood pumped out per beat by the heart's left ventricle.

Recently, the Food & Drug Administration (FDA) received information from a postmarketing safety study that demonstrated poor adherence to the monitoring recommendations made in 2005 in clinical practice. This study used insurance-claims data and medical-record reviews to examine cardiac monitoring patterns in clinical practice. In this study, it was noted that four patients developed congestive heart failure 4 to 17 months after completing therapy with Novantrone.

The FDA is now working with the manufacturers of Novantrone to remind healthcare professionals of the importance of adhering to the recommendations for patients with MS who are treated with Novantrone and generic equivalents.

The FDA and the manufacturers are now advising that all patients with MS who have finished treatment with mitoxantrone receive yearly quantitative LVEF evaluations to detect late-occurring cardiac toxicity.  

The FDA has issued the following recommendations for patients treated with mitoxantrone.

For all patients

  • Assess signs and symptoms of cardiac disease with a history, physical examination, and ECG before initiating therapy with mitoxantrone.
  • Perform a baseline quantitative evaluation of LVEF.
For patients with MS

  • Patients with a baseline LVEF below the lower limit of normal should not be treated with mitoxantrone.
  • Patients should be assessed for cardiac signs and symptoms with a history, physical examination, and ECG before each dose.
  • Patients should undergo a quantitative reevaluation of LVEF before each dose, using the same methodology for each assessment. Additional doses of mitoxantrone should not be administered to patients who have experienced either a drop in LVEF to below the lower limit of normal or a clinically significant reduction in LVEF during mitoxantrone therapy.
  • Patients should not receive a cumulative mitoxantrone dose greater than 140 mg/m2.
  • Patients should undergo yearly quantitative LVEF evaluations after stopping mitoxantrone to monitor for late-occurring cardiotoxicity, using the same methodology that was used for assessments that were done during treatment.

For patients with cancer

  • The possible danger of cardiac effects in patients previously treated with daunorubicin or doxorubicin should be considered when weighing the benefits and risks of mitoxantrone.
  • The presence or history of cardiovascular disease, previous or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or the concomitant use of other cardiotoxic drugs might increase the risk of cardiac toxicity. LVEF should be monitored regularly after the initiation of therapy in patients with these risk factors.

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