FDA Issues Reminder Novantrone Warning

The FDA issued a health alert yesterday to neurological and oncological healthcare providers who use Novantrone and generic mitoxantrone. The statement was sent as a reminder about previous recommendations which have been issued about the safe use of the drug.

Doctors who use Novantrone have been urged to evaluate left ventricular ejection fraction (LVEF) before each treatment, to monitor for possible cardiac toxicity and to provide information to patients with multiple sclerosis who receive the drug.

Novantrone (mitoxantrone hydrochloride for injection concentrate) is an immunosuppressant used for treatment of secondary progressive forms of multiple sclerosis (SPMS), leukemia and other types of cancer. The medication, which is injected intravenously, was approved for treatment of SPMS in October 2000 and is currently manufactured by EMD Serono, Inc. and OSI Pharmaceuticals, Inc.

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The medication is effective against multiple sclerosis in the short term, reducing relapses and disability. However, it is not intended for long-term therapy because it can cause severe dose-dependent cardiotoxicity, liver damage and congestive heart failure (CHF). Other Novanntrone side effects include nausea, chest pain, temporary hair loss, diarrhea, skin rash and mouth sores.

According to the FDA, case reports in medical literature and post marketing adverse event reports indicate that Novantrone and generic mitoxantrone can result in decreases in LVEF, a sign of impaired heart function, and congestive heart failure in MS patients who received cumulative doses of Novantrone that were less than 100mg/m2 of body surface area.

In March 2005, the warning label of Novantrone was amended to indicate that LVEF needs to be evaluated in multiple sclerosis patients before initiating mitoxantrone treatment and before each dose of the drug is given. Recommendations were also added that cardiac monitoring should be carried out to detect cardiac toxicity that may have developed during or after termination of treatment.

The FDA alert was issued as a reminder to doctors, since the agency indicates that they continue to see poor adherence to the recommendations in clinical practice. The FDA is currently working with the manufacturers of Novantrone and generic mitoxantrone hydrochloride to educate healthcare providers about the importance of cardiac monitoring in multiple sclerosis patients using the drug.

Healthcare providers are also asked to ensure that MS patients who have completed mitoxantrone treatment receive annual quantitative LVEF evaluation to detect cardiac toxicity that may develop later. All MS patients are also to be informed about the risks and problems that may develop when using the drug.

8 Comments

  • CordeliaJanuary 2, 2016 at 1:05 am

    Have ms recieved navatrone and had congestive heart failure 9months ago

  • MattNovember 20, 2015 at 12:36 am

    Matt again. Just keeping this thread alive and agree with Robert above -- this drug needs to be looked at closely.

  • RobertOctober 5, 2015 at 10:10 pm

    I was my sisters caregiver for 18 years. She was diagnosed with MS in 1980 but we are certain she had it way before that it is just they at the time were not good at diagnosing MS. Seven years ago she was given novantrone by her norologist and at the end of two years of treatments her Norologist told her her heart was fine and to stay on the drug that next year she developed chronic heart failur[Show More]I was my sisters caregiver for 18 years. She was diagnosed with MS in 1980 but we are certain she had it way before that it is just they at the time were not good at diagnosing MS. Seven years ago she was given novantrone by her norologist and at the end of two years of treatments her Norologist told her her heart was fine and to stay on the drug that next year she developed chronic heart failure. She died in September of 2015 and I am certain the underlying cause of death was Novantrone and medical incompetence. If any of you know of a law firm or a class action lawsuit against immunex the makers of Novantrone please inform me This drug needs to be taken off the marker

  • MattOctober 25, 2011 at 10:33 pm

    Father, 66 had acute monocytic leukemia (M5). He was given Novantrone for 1 month. Several warning signs emerged as he began to have heart trouble. No LVEF monitoring was conducted. He arrested 1 month after induction and was anoxic for at least 8 minutes suffering severe brain damage. He died 3 months later as we were not able to treat given his condition. I am 100% confident Novantorne was[Show More]Father, 66 had acute monocytic leukemia (M5). He was given Novantrone for 1 month. Several warning signs emerged as he began to have heart trouble. No LVEF monitoring was conducted. He arrested 1 month after induction and was anoxic for at least 8 minutes suffering severe brain damage. He died 3 months later as we were not able to treat given his condition. I am 100% confident Novantorne was the cause of the heart problems - and the doctors knew it too. I'm getting the word out. I think it's a matter of time before they put 2 and 2 together.

  • FionaJanuary 3, 2011 at 9:29 pm

    I too was treated with Novantrone for SPMS. I had 5 or 6 infusions and then stopped as my MS was still progressing. I had one heart scan prior to starting treatment, and although FDA had issued the above letter while I was still being treated, I did not have another heart scan until several years later when my neurologist (not the oncologist who treated with Novantrone) ordered one as he was conc[Show More]I too was treated with Novantrone for SPMS. I had 5 or 6 infusions and then stopped as my MS was still progressing. I had one heart scan prior to starting treatment, and although FDA had issued the above letter while I was still being treated, I did not have another heart scan until several years later when my neurologist (not the oncologist who treated with Novantrone) ordered one as he was concerned with data emerging about the risks from the drug. I have since had another ECG, both of which show some abnormal findings (thickening of atrial wall/valve) and possible cardiomyopathy. I am 53 years old and had no prior history of any heart problems.

  • MichaelJuly 17, 2010 at 4:40 pm

    I am a 57 year old male, who has MS and was treated with Novantrone. I did 4 treatments and aprox. 12 months after my last treatment I was diagnosed with MDS (Leukemia). which has been stated that it is treatment related leukemia ,I am in the process of a stem cell transplant to try and cure this. I believe that Novantrone is responsible for my luekemia

  • aaronMay 15, 2009 at 3:57 pm

    I have MS and was treated with mitoxantorine 5 years ago. Just recently developed Leukemia from the treatment abd the Doctors say it wasa side effect from the treatment. I am not the only one this has happened to and it is well documented.

  • SheilaMarch 29, 2009 at 2:57 am

    I am 57 and had a heart attack 3 weeks ago. I ate a very healthy diet, had normal blood pressure and cholesterol, did yoga twice a week and did not smoke, drink, or have a family history of heart attack it happened. I have secondary progressive MS and was treated with Novantrone approx. 2 years ago. I had an echocardiogram before each treatment but have not had another one since stopping treatm[Show More]I am 57 and had a heart attack 3 weeks ago. I ate a very healthy diet, had normal blood pressure and cholesterol, did yoga twice a week and did not smoke, drink, or have a family history of heart attack it happened. I have secondary progressive MS and was treated with Novantrone approx. 2 years ago. I had an echocardiogram before each treatment but have not had another one since stopping treatment. Could this just be a coincidence?

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