Tysabri – new side-effects to be added

(article date: 24 Mar 2008)

The European Medicines Agency (EMEA) has concluded that warnings about liver injury should be added to the product information for Tysabri (natalizumab).

Tysabri is used to treat relapsing-remitting multiple sclerosis (MS) in patients with high disease activity despite treatment with a beta-interferon or whose disease is severe and evolving rapidly.

Following a review of reports of liver injury in patients treated with Tysabri, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to update the product information for Tysabri to warn patients and prescribers that liver injury may occur.

Doctors should monitor the liver function of patients receiving Tysabri. Patients who observe any signs of liver injury, such as yellowing of the skin or the whites of the eyes, or unusual darkening of the urine should see their doctor!!!

— Medical News Today


Food factors causing attacks…?

Dietary changes are not the mainstay of traditional treatment for MS. Still, some say dietary changes can make a difference in the course of the disease, says Mary Dan Eades, M.D., director of the Arkansas Center for Health and Weight Control in Little Rock and author of The Doctor’s Guide to Vitamins and Minerals.

Switch fats. Some evidence suggests that trimming saturated fat and increasing intake of two essential fatty acids, gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA), can help people with MS, says Dr. Eades.

Doctors who recommend this sort of diet may have their MS patients cut their saturated fat intakes to about 10 percent of calories by eliminating fatty meats, butter, mayonnaise, whole milk and cheeses, according to Dr. Eades. Then to keep fat intake at about 25 to 30 percent of calories, doctors have their patients add supplements of GLA (from evening primrose oil or borage oil) and EPA (from fatty fish), she says.

(Dr. Eades prescribes one part GLA to four parts EPA, a ratio that’s found in a product called EicoPro. EicoPro, manufactured by EicoTech of Marblehead, Massachusetts, is an essential fatty acid product that contains ultrapure sources of GLA and EPA.)

As previously mentioned on this blog, the main proponent of the low-fat diet (in the US…) is Dr. Swank, of the Swank Multiple Sclerosis Clinic in Beaverton, Oregon. Dr. Swank has his patients stick to 10-15 grams of saturated fat and 20 grams of unsaturated oils (such as safflower oil, sunflower oil, olive oil and cod liver oil) daily. He has had 150 patients who have been on this diet for more than 35 years.

“We’ve been following patients for 40 years, and without question, animal fat is the real culprit in this disease,” Dr. Swank contends. “This diet has helped more than 3,000 MS patients worldwide. It helps anyone at any stage of the disease but prevents disability in 95 percent of patients when it’s started before disability has developed.”

Bulk up with bran. To coax the sluggish bowel associated with MS, get plenty of fiber every day, urges Timothy Vollmer, M.D., medical and research director of the Rocky Mountain Multiple Sclerosis Center in Englewood, Colorado. Whole grains, fruits, vegetables and beans can all help keep you regular.

Drink plenty of water. Getting lots of water relieves constipation, too. And it can ward off the bladder infections that can plague people with MS, Dr. Vollmer says. (Try cranberry juice for extra infection-fighting power.)

Find your food foes. The idea that food allergies or intolerances can contribute to symptoms of MS remains entirely unproven. Still, some doctors believe that for some people, certain foods can trigger or worsen symptoms.

Two Dutch doctors cite several reports of people whose symptoms worsened. One case report implicates fresh pineapple as the cause of a woman’s muscle weakness and loss of vision. And in the United States and 21 other countries, the incidence of MS correlates most strikingly with milk consumption, according to one survey.

Common sense suggests that if your symptoms seem to worsen after eating a particular food, drop that food from your diet for at least a few weeks to see if you notice improvement.

Vitamin B12 & MS…

There appear to be some potential links between the nutrient, which is so essential for proper nerve function, and this debilitating disease. For instance, vitamin B12 deficiency can mimic some of the symptoms of MS, such as numbness and tingling in the arms and legs, loss of balance and fatigue, says Donald W. Jacobsen, Ph.D., director of the Department of Cell Biology at the Cleveland Clinic.

“A severe vitamin B12 deficiency can cause breakdown of the myelin sheath, similar to what occurs in MS,” Dr. Jacobsen says. That’s why many doctors test for B12 deficiency if you have symptoms of MS. Although most people get enough B12 in their diets, absorption problems can cause a B12 shortage, especially in people ages 60 and older. If you have absorption problems, you’ll probably have to get B12 shots or possibly include daily supplements in your diet for the rest of your life, depending on your particular case.

Studies are mixed as to how many people diagnosed with MS or with MS-like symptoms have low blood levels of vitamin B12, Dr. Jacobsen says. For example, a study by British researchers found that a fairly high number of people with MS have low blood levels of B12. On the other hand, researchers at the Cleveland Clinic, using tests that measure blood levels of B12 and two B12-related compounds, homocysteine and methylmalonic acid, found fewer B12-deficient people than did the British.

“At this point, we just don’t know what to make of all of this,” Dr. Jacobsen says. “We still feel like we are missing major pieces of the puzzle. It’s still an open question whether true, functional vitamin B12 deficiency exists in MS.”

To complicate matters further, people with MS often have what’s called mild macrocytosis. They have some larger than normal but immature red blood cells in their blood that resemble a budding case of pernicious anemia, a disease that is associated with severe vitamin B12 deficiency. Most, however, never go on to develop a full-blown case of pernicious anemia.

Your doctor can determine with a few tests whether you’re having absorption problems. If it turns out that you do have an absorption problem, you’ll need to get injections of vitamin B12 from your doctor. If you don’t have absorption problems, you can safely take oral doses of up to 500 micrograms of B12 a day, Dr. Jacobsen says. (This amount is many times the Daily Value of B12, which is only 6 micrograms.)

It’s also important to have your doctor check your blood levels of the B vitamin folate (the naturally occurring form of folic acid), Dr. Jacobsen says. That’s because folate deficiency can cause symptoms similar to vitamin B12 deficiency, although its neurological consequences are much less severe. If you’re found deficient, you’ll have to take oral folic acid supplements to get your blood level back to normal. You shouldn’t take folic acid unless your doctor recommends it, says Dr. Jacobsen.

Nutrient Daily Amount…

DRUGS are the mainstay of treatment for MS. However, there are a few nutrients that may prove helpful. Here’s what some doctors recommend…

Selenium 100 micrograms

Vitamin B12 500 micrograms

Vitamin C 1,000­2,000 milligrams, taken as 2­4 divided doses

Vitamin E 800 international units

Plus a multivitamin/mineral supplement containing the Daily Values of all essential vitamins and minerals


MEDICAL ALERT: If you have been diagnosed with multiple sclerosis, you should be under a doctor’s care.

Injections of vitamin B12 are required for people who have problems absorbing this nutrient.

Vitamin C in doses exceeding 1,200 milligrams a day can cause diarrhea in some people.

It’s a good idea to check with your doctor before taking more than 600 international units of vitamin E a day. If you are taking anticoagulant drugs, you should not take vitamin E supplements.

Antioxidant Nutrients May Help..?

There’s some evidence that the damage to a nerve’s fatty sheath, associated with MS, is caused by what is known as oxidative injury. That damage, also called lipid (fat) peroxidation, occurs because unstable molecules called free radicals steal electrons from the healthy molecules in this fatty covering, causing breakdown and scarring that eventually destroys the nerve. Free radicals can be generated by attacking immune cells. They also occur when the body is exposed to certain toxic chemicals. Researchers in Chicago found that people experiencing MS attacks had significantly higher levels of pentane, a by-product of lipid peroxidation, in their breath than they did when their symptoms were in remission.

“Our findings very much support the theory that the mechanism for destruction in MS is associated with free radicals,” says Edwin Zarling, M.D., associate professor of medicine at Loyola University of Chicago Stritch School of Medicine in Maywood, Illinois, and a researcher for the Cook County Hospital study. “Our work shows that antioxidants should be tried for MS.” Studies have yet to be done that show antioxidants help people with MS, he adds.

Because of these findings, some doctors recommend that their patients with MS take the array of so-called antioxidant nutrients, which neutralize free radicals by offering up their own electrons, protecting your body’s healthy molecules from harm. These nutrients include vitamins C and E, beta-carotene and the mineral selenium. Amounts recommended can vary widely.

“I recommend taking at least 500 milligrams of vitamin C two to four times a day and 100 micrograms of selenium and 800 international units of vitamin E once a day,” says Mary Dan Eades, M.D., medical director of the Arkansas Center for Health and Weight Control in Little Rock and author of The Doctor’s Guide to Vitamins and Minerals.

It’s a good idea to check with your doctor before taking more than 600 international units of vitamin E a day. Vitamin C in doses exceeding 1,200 milligrams a day can cause diarrhea in some people.

(how to…) Manage your life with MS…

An interesting story on how you can ‘manage MS’ (one of the many ways of course:)

Leonard Flynn, an organic chemist, was diagnosed with MS in 1988. He believes he is healthier now than he has been in years. To prove it, he amazingly climbed Mount Scenery, a peak that has more than 1000 stony steps cut into its steep side. He attributes his improved health to a low-saturated-fat diet that some studies suggest slows the course of this disease.

(For instance, the Swank MS Diet is a low saturated fat diet used for the management of MS championed by Dr. Roy L. Swank since 1948. The results of his study showed that those who followed the diet had not shown any significant deterioration of their condition over a 34 year period. Conversely, those that did not follow the diet did significantly deteriorate over the same period. More recent articles, have shown that after 44 years, the patients who had continued to follow this diet had not shown any significant deterioration of their condition. However, Dr. Swank’s research has been disputed by some, due to lacking documented double blind testing. For that reason, many in the medical community do not accept the Swank Diet as a treatment for MS.)

Leonard Flynn also takes the same antioxidant nutrients thought to protect against cancer and heart disease: vitamins C and E, selenium and beta-carotene, the yellow pigment found in carrots, cantaloupe and other orange and yellow fruits and vegetables. Plus he eats lots of fatty fish, mostly sardines, salmon and water-packed tuna, and relies on sunflower oil and safflower oil for additional fat.


This is not to say that MS isn’t a serious condition or that it can be cured by a particular diet. But there are ways to make life with MS easier. A healthy diet is important to maximize function and to decrease the disability that occurs in MS.

‘B Vitamin Prevents MS Disability in Mice’

I hope they’ve started on the clinical trial since then… :o)

Journal of Neuroscience, September 20, 2006

BOSTON, Sept. 20 — A form of niacin may be a novel treatment for chronic progressive multiple sclerosis, according to researchers here.n a mouse model of MS, nicotinamide — the amide form of niacin, or vitamin B3 — significantly prevented neurological disability, said Shinjiro Kaneko, M.D., of Children’s Hospital Boston.The finding, reported in the Sept. 20 issue of Journal of Neuroscience, raises the possibility that the vitamin “may be a promising candidate as a neuroprotective treatment for MS patients,” said Dr. Kaneko and colleagues.

This research sounds very promising too…don’t know if they started on the clinical trials yet..would be nice…

(for the whole article check under ‘links’:o)

Previous Older Entries