FDA: Cardiac monitoring critical in MS patients taking mitoxantrone
FDA also issued a new recommendation for MS patients who have had treatment with mitoxantrone.
Because many multiple sclerosis patients taking mitoxantrone (Novantrone, Immunex) are not having their cardiac functions monitored as recommended, the Food & Drug Administration just sent an alert out to health professionals to remind them of the importance of this task. In addition, the agency issued a new recommendation. All MS patients who have finished treatment with mitoxantrone should receive yearly quantitative left ventricular ejection fraction (LVEF) evaluation to detect late-occurring cardiac toxicity.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
