Mitoxantrone,
a multiple sclerosis (MS) drug that is already associated
with a higher risk for leukemia and heart damage, may also raise a
person’s risk of colorectal cancer, researchers at
the University
of Würzburg,
Germany, reported. If confirmed in larger studies, the
findings indicate that colonoscopies should be conducted on MS
patients after mitoxantrone treatment to monitor them for
this cancer.
The
article, “Malignancies
after mitoxantrone for multiple sclerosis: A retrospective
cohort study,”
was published in the journal Neurology.
Mitoxantrone
is prescribed to patients with progressive MS, a notoriously
difficult-to-treat MS subtype, and aggressive types of
relapsing-remitting MS that do not respond to other treatments. First
developed as a chemotherapy, the drug was approved in 2000 for MS
because it powerfully suppresses the immune system.
In
a retrospective study into the risk of malignancies related
to the drug, researchers analyzed clinical data from
mitoxantrone-treated MS patients between 1994 and 2007, and collected
data on confirmed malignancies, life status, and cause of death as of
2010.
Of
the 676 patients analyzed, 37 (5.5%) were diagnosed with cancer after
mitoxantrone treatment initiation, including nine people with
breast cancer, seven with colorectal cancer, and four with acute
myeloid leukemia. Compared with the German national cancer registry
matched for sex, age, and year of occurrence, the rate of leukemia
was 10 times higher in mitoxantrone patients. For
colorectal cancer, the rate was three times higher among treated
patients. No increased risk for breast cancer and other
malignancies was associated with mitoxantrone. Three of the
people diagnosed with colorectal cancer died during the study.
Researchers
also found that the incidence of colorectal cancer and leukemia was
not increased by factors such as drug dose, gender, or treatment with
other immunosuppressant drugs. Only older age was related to a higher
risk for cancer.
Still,
the authors believe that mitoxantrone is a valuable therapy for MS
patients.
“Despite
an increased risk of acute myeloid leukemia and colorectal cancer,
the overall rate of cancer was low enough to justify still using this
drug for people severely affected by MS if no better treatment is
available,” said Mathias Buttmann, MD, the study’s
first author, in a press
release.
“Mitoxantrone is the only approved treatment for people with
secondary progressive MS without relapses, and should be considered
in people where the disease is evolving quickly. Also, many of the
new and highly effective MS drugs are not available to people in a
number of countries for economic reasons, so mitoxantrone is being
used for people with very active relapsing forms of the disease.”
Natural Remedies for MS
Courtesy of email from Health Sciences Institute: Code Red Alert
Some helpful vitamins, herbs and supplements for MS
Agrimony (Agrimonia)
Amrit Kalash
Ashwagandha
Astralagus
Barberry
Bee Pollen
Bee Venom - This has not been tested to prove to be beneficial
Bilberry Leaf
Burdock Root
Calcium
Catnip
Chamomile
Chyawanprash
Cramp Bark
Cranberry
Coenzyme Q10
Dandelion Root & Leaf
DHA
Echinacea
Elderflower
Fish or Cod Liver Oil
Ginger
Gingko Biloba
Ginseng
Gotu Kola
Hawthorn Berry
Huo Ma Ren (Chinese Hemp Seed)
Lemongrass
Licorice
Magnesium
Milk Thistle
Mineral Oil
Multimineral & Multivitamin Supplements
Myrrh
Oat Seed or Oat Straw
Omega-3 & Omega-6 Essential Fatty Acids
Peppermint
Polyunsaturated Fatty Acids (PUFAs)
Probiotics
Red Clover
Sage
Schizandra Berry
Selenium
Skullcap
Slippery Elm
Soy Lecithin
St. John’s Wort
Stevia
Turmeric
Valerian
Vitamin A
Vitamin B1 (Thiamine)
Vitamin B6
Vitamin B12
Vitamin C
Vitamin D
Vitamin E
Wood Betony
Yucca
Zinc
Death reported after first dose of this MS drug
Within 24 hours of taking the first dose of Gilenya (a newly approved drug used to treat relapsing MS symptoms) a patient died.Now, the investigation is still open, and we can't say that the drug definitely caused the death, but evidence does point that way. And the FDA was shaken enough to put out a warning right away, even though they aren't pulling the drug, or even recommending that MS patients stop taking it.
The facts:
- Even the first dose of Gilenya is known to potentially cause very serious side effects, including decreased heart rate (bradycardia). That usually doesn't cause obvious symptoms, so you might not even know it's happening!
- Doctors are supposed to watch all patients taking this medicine for 6 full hours after the first dose to make sure they don't suffer bradycardia.
- The patient who died within 24 hours of taking the first dose of Gilenya had been through the 6 hours of monitoring "without incident," but died within the next 18 hours.
- The danger is higher for patients also taking beta-blockers or calcium channel blockers (which the dead patient was known to be taking)
On top of that, Gilenya's warning label also includes increased risk of infection, which continues for up to two months after you stop taking Gilenya.
If you're considering trying this drug to treat MS symptoms, please reconsider: even the first dose could be disastrous.
If you're considering trying this drug to treat MS symptoms, please reconsider: even the first dose could be disastrous.
Within 24 hours of taking the first dose of Gilenya (a newly approved drug used to treat relapsing MS symptoms) a patient died.
FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)
Safety AnnouncementAdditional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
Safety Announcement
[12-20-2011] The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.
Facts about Gilenya (fingolimod)
|
|
Patients with MS should not stop taking Gilenya without talking to their healthcare professional.
FDA will communicate any new information on Gilenya and this case when it becomes available.
Additional Information for Patients
- Gilenya may cause serious side effects, such as slow heart rate (bradycardia), which may be related to slowed conduction of electrical impulses from the upper chambers of the heart to the lower chambers of the heart. These effects usually do not cause symptoms, but they can cause dizziness, fatigue, and palpitations.
- A slowing of the heart rate due to Gilenya mostly occurs after the first dose, and your heart rate usually returns to normal within 1 month after you start taking the drug.
- Call your healthcare professional and seek immediate care if you develop any signs or symptoms of slow heart rate such as
- Dizziness
- Tiredness
- Slow or irregular heart beat or palpitations
- Discuss any questions or concerns about Gilenya with your healthcare professional.
- Report any side effects you experience to your healthcare professional and the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.
Additional Information for Healthcare Professionals
- If you prescribe Gilenya, carefully follow the recommendations in the Gilenya drug label.
- Observe all patients for signs and symptoms of bradycardia for 6 hours after the first dose.
- Obtain a baseline ECG before the first dose if one was not recently performed for those patients at higher risk of bradyarrhythmias.
- Gilenya has not been studied in patients with ischemic heart disease, congestive heart failure, second degree or higher conduction block, sick sinus syndrome, or prolonged QT interval. Gilenya has not been studied with concomitant use of Class Ia or Class III antiarrhythmic agents. These patients, as well as patients receiving beta blockers, calcium channel blockers, and those with a low heart rate or history of syncope, are at increased risk of developing bradycardia and conduction block. Carefully monitor these patients during initiation of therapy.
- If Gilenya therapy is discontinued for more than two weeks, the effects on heart rate and atrioventricular (AV) conduction may recur on reintroduction of Gilenya treatment and the same precautions and monitoring as for initial dosing should be followed.
- Make sure your patients know the signs and symptoms of bradycardia and when to seek care.
- Report adverse events involving Gilenya to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.
Data Summary
FDA is evaluating a post-marketing report submitted to FDA's Adverse Events Reporting System (AERS) database regarding a patient who died within 24 hours of taking the first dose of Gilenya (fingolimod). The patient was also treated with metoprolol, a beta blocker, and amlodipine, a calcium channel blocker. The patient had completed 6 hours of monitoring after the first dose without incident, but died less than 24 hours after the first dose. The exact cause of death has not been established. FDA is working closely with the manufacturer of Gilenya (Novartis Pharmaceuticals) to evaluate the post-market report of death.
Gilenya has several known side effects which include a decrease in heart rate and/or atrioventricular conduction after the first dose. Patients receiving Class Ia or Class III antiarrhythmic drugs, beta blockers, calcium channel blockers, those with a low heart rate, history of syncope, sick sinus syndrome, 2nd degree or higher conduction block, ischemic heart disease, or congestive heart failure are at increased risk of developing bradycardia or heart blocks. [See the Gilenya drug label for complete information on Warnings and Precautions]
At this time, FDA believes the benefits of Gilenya continue to exceed the potential risks when the drug is used appropriately as described in the approved drug label. FDA recommends that healthcare professionals continue to prescribe Gilenya following the recommendations in the drug label.
I received an email from msviewsandnews.org Kind of scary info.
Potentially Harmful Supplements for People with MS
MS Diet for women |
