Safety Alerts & Recalls

What does this mean?

The heart problems associated with the administration of mitoxantrone (Novantrone) are widely known. Cardiac monitoring prior to administering each dose has been recommended for many years. This alert is to remind you to speak to your doctor and review the plan to monitor how your heart is working during and after your treatment with mitoxantrone (Novantrone).

Cardiac monitoring recommended

The FDA recently reminded health care professionals that cardiac monitoring should be conducted prior to administering mitoxantrone (Novantrone) to patients. The FDA and manufacturers of mitoxantrone (Novantrone) also recommended that patients receive yearly cardiac monitoring after they have finished mitoxantrone (Novantrone) treatment. Mitoxantrone (Novantrone) has been linked to cases of heart failure and other heart problems. Cardiac monitoring may help with early detection of these heart problems.

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Source: FDA
Publication Date: 2008-07-30
Last Updated: 2009-12-06

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