Risks of Novantrone Treatment of MS: James Lehrich, MD, is a Neurologist at Massachusetts General Hospital and an Associate Professor of Neurology at Harvard Medical School.

Clinicl relevance: The authors call attention to new labeling for Novantrone use in treatment of patients with worsening MS. Review of postmarketing reports submitted to the FDA identified patients who experienced decreases in left ventricular ejection fraction (LVEF) with and without clinically significant congestive heart failure, occurring at cumulative doses of less than 100 mg per square meter, and in some patients as low as 37.5. Because of the risk of cardiac toxicity, new package labeling mandated by the FDA now requires evaluation by echocardiogram or multiple gated radionuclide angiography (MUGA) prior to the first dose and before each subsequent dose of Novantrone, as well as whenever the patient develops symptoms and signs of heart failure.

Commercial relevance: Although Novantrone cardiotoxicity has been well known, these data suggest risks of decline in LVEF at cumulative doses well below the previously recommended cumulative threshold for monitoring. Neurologists may now recommend Novantrone treatment to fewer of their MS patients..