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Aubagio Approved for Multiple Sclerosis

Posted 13 Sep 2012 by Drugs.com

THURSDAY, Sept. 13 – Aubagio (teriflunomide) has been approved by the U.S. Food and Drug Administration to treat adults with relapsing forms of multiple sclerosis (MS). MS is a chronic inflammatory disease that affects communication between the brain and other parts of the body. About twice as prevalent in women than men, it's among the most common causes of neurological disability in young adults, the FDA said in a news release. The drug's label contains the FDA's most stringent black box warning, alerting doctors and patients to the possibility of deadly liver problems. Doctors are advised to perform blood tests of liver function before and during treatment, the agency said. Aubagio's label also advises that the drug could harm a developing fetus. So, women of childbearing age must have a negative pregnancy test before beginning treatment and take effective birth control during ... Read more

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FDA Approves New Multiple Sclerosis Treatment Aubagio

Posted 12 Sep 2012 by Drugs.com

September 12, 2012 – The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). “In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.” MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men ... Read more

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Study Casts Doubt on Link Between MS and Vein Trouble

Posted 21 Aug 2012 by Drugs.com

TUESDAY, Aug. 21 – Changes in blood flow due to abnormalities in veins draining from the brain are not linked to multiple sclerosis, according to a new study. Researchers in Italy found that compromised blood flow in the veins that drain blood from the brain are not associated with the severity of multiple sclerosis (MS), which can cause numbness, trouble moving, blurred vision and fatigue, as well as problems with thinking and memory. The researchers, from University of Rome Tor Vergata, noted that their findings challenge previous speculation that the condition, called chronic cerebrospinal venous insufficiency (CCSVI), is specific to MS and can be treated with endovascular procedures such as stents. Researchers compared the brain blood flow of 39 people with MS to that of 26 healthy people. Twenty-five of the MS patients and 14 of the healthy people met the criteria for CCSVI. The ... Read more

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In Mice, Alzheimer's-Linked Protein Shows Promise Against MS

Posted 1 Aug 2012 by Drugs.com

WEDNESDAY, Aug. 1 – The amyloid beta protein, long tied to Alzheimer's disease, may actually help reverse paralysis and inflammation in people with multiple sclerosis (MS). So finds a study involving mice, conducted by researchers at Stanford University School of Medicine. While attempting to slow the progression of Alzheimer's disease, they unexpectedly stumbled upon this promising new avenue for the treatment of MS. "There probably is a multiple sclerosis drug in all this somewhere down the line," study senior author Dr. Lawrence Steinman speculated in a university news release. The study is published online Aug. 1 in the journal Science Translational Medicine. Amyloid beta is the chief component of the plaques that accumulate in the brains of people with Alzheimer's disease. This substance builds up during the normal aging process or following a brain injury. It is also found in ... Read more

Related support groups: Multiple Sclerosis, Alzheimer's Disease

FDA Medwatch Alert: Ampyra (dalfampridine): Drug Safety Communication - Seizure Risk for Multiple Sclerosis Patients

Posted 23 Jul 2012 by Drugs.com

ISSUE: FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine).  The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. The FDA is updating the Ampyra drug label to clarify recommendations. BACKGROUND: Ampyra was approved to improve walking in patients with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug.  Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk.  R ... Read more

Related support groups: Multiple Sclerosis, Ampyra, Dalfampridine

Drug Widely Used to Treat MS May Not Slow Progression

Posted 17 Jul 2012 by Drugs.com

TUESDAY, July 17 – Interferon beta, a widely used treatment for multiple sclerosis, does not stave off the time to disability, new research finds. However, prior studies have found that interferon beta does reduce MS flare ups, so patients should continue taking it, researchers said. The new study is published in the July 18 issue of the Journal of the American Medical Association. In multiple sclerosis, the body's immune system attacks myelin, or the substance that insulates nerve fibers of the central nervous system. The damage disrupts nerve signals traveling to and from the brain, which can lead to numbness, movement difficulties, blurred vision, fatigue and eventually, problems with thinking and memory. About 85 percent of those with multiple sclerosis start with a relapsing-remitting course, in which attacks are followed by partial or total recovery, according to the National ... Read more

Related support groups: Multiple Sclerosis, Avonex, Rebif, Betaseron, Interferon Beta-1A, Interferon Beta-1B, Avonex Prefilled Syringe, Extavia

Scientists Pinpoint Antibody That May Be Specific to MS Patients

Posted 11 Jul 2012 by Drugs.com

WEDNESDAY, July 11 – Researchers have identified an antibody found in the blood of about half of patients with multiple sclerosis that is not found in people without the autoimmune disease. The implications of the antibody's presence aren't fully understood. But in rodents, the antibody binds to and damages brain cells that are known to be important to neurological function, according to the study. Although the research is preliminary, experts say the findings may open the door for a blood test that could more easily diagnosis multiple sclerosis (MS) patients. The results also suggest a new target for MS treatments that would prevent the antibody from binding to brain cells. "We have known for a long time that antibodies were involved in the destruction of nervous system tissue in MS, but we have not had a good handle on what the target was for these antibodies," said Timothy Coetzee, ... Read more

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Does Stress Management Slow MS?

Posted 11 Jul 2012 by Drugs.com

WEDNESDAY, July 11 – When researcher David Mohr began working with people with multiple sclerosis about 20 years ago, patients would tell him that stress made their disease worse. At the time, most physicians didn't believe there was a connection, he said. But a study published online July 11 in Neurology adds to growing evidence that suggests a link between stress and flare-ups of the neurological disease. The research shows that participating in weekly stress management therapy prevented the development of new brain lesions, indicators of the impact of the disease in the brain. But not long after the treatment stopped, new brain lesions appeared. "It's clear that stress plays an important role in multiple sclerosis, and therapy may be a useful additional treatment, along with drug therapy," said Mohr, author of the study and professor of preventive medicine at Northwestern University ... Read more

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Botox May Ease Tremors in Multiple Sclerosis Patients

Posted 2 Jul 2012 by Drugs.com

MONDAY, July 2 – The drug Botox, best known for paralyzing muscles in the forehead to reduce wrinkles, can also relieve shaking in the limbs of patients with multiple sclerosis, a small new study suggests. The treatment, which requires several times the amount of Botox (botulinum toxin type A) used for wrinkles, could be expensive and it's not yet approved by the U.S. Food and Drug Administration for this use. However, multiple sclerosis (MS) patients can still legally get the treatment in the United States. "Most patients tolerate the injections very well and are keen to continue the treatment once they see the benefits they get from it," said Dr. Anneke van der Walt, lead study author and a neurologist and research fellow at the Royal Melbourne Hospital, in Australia. The shaking, known as a tremor, can affect one or both arms, or less commonly the legs, in MS patients. "The shaking ... Read more

Related support groups: Multiple Sclerosis, Botox, Botox Cosmetic, Onabotulinumtoxina

Fertility Treatment Tied to Higher Relapse Rate in Women With MS

Posted 13 Jun 2012 by Drugs.com

WEDNESDAY, June 13 – Women with multiple sclerosis (MS) who undergo in vitro fertilization therapy are more likely to suffer a relapse of their MS condition, according to the results of a small new study. The use of synthetic hormonal chemicals, such as gonadotropin, during fertility treatments may be to blame for the increased relapse rate, the study authors suggested. They said women with MS should be warned about their greater risk for relapse following in vitro fertilization, particularly if the treatment is unsuccessful. The study by researcher David-Axel Laplaud of INSERM, Nantes, France, and colleagues was published online June 11 in the Journal of Neurology, Neurosurgery and Psychiatry. Previous research suggests that sex-hormone therapy and pregnancy affect the MS relapse rate, according to a journal news release. To determine if the synthetic hormonal treatments used during ... Read more

Related support groups: Multiple Sclerosis, Female Infertility

Study Shows MS Patients at Most Risk for Drug-Linked Brain Illness

Posted 16 May 2012 by Drugs.com

WEDNESDAY, May 16 – Drug company researchers say they've determined which multiple sclerosis patients are most vulnerable to developing a rare brain infection while taking a powerful drug called Tysabri (natalizumab). Even the multiple sclerosis patients at highest risk of developing the brain infection face low odds of getting it while on Tysabri, but the infection can be deadly. "Now we can identify which risk group each patient is in. This will help doctors and patients make better decisions," said Dr. Gary Bloomgren, lead author of a study released Wednesday and vice president of drug safety at Biogen Idec, which makes the drug. About 100,000 patients have taken Tysabri at least once. The drug, which is used mainly to delay the progression of multiple sclerosis, has been on the market since 2006. It originally went on the market in 2005 but was removed due to medical problems that ... Read more

Related support groups: Multiple Sclerosis, Tysabri, Natalizumab

FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

Posted 15 May 2012 by Drugs.com

[UPDATED 05/14/2012] FDA has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. FDA could not definitively conclude that Gilenya was related to any of the deaths. However, based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients. For this reason, Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last ... Read more

Related support groups: Multiple Sclerosis, Gilenya, Fingolimod

FDA Issues Multiple Sclerosis Drug Alert

Posted 14 May 2012 by Drugs.com

MONDAY, May 14 – The multiple sclerosis drug Gilenya (fingolimod) should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems, says a U.S. Food and Drug Administration safety announcement issued Monday. The warning follows the FDA's evaluation of a report of a patient who died within 24 hours after receiving the first dose of Gilenya. The agency also reviewed additional clinical trial and post-approval data for the drug, including reports of patients who died of cardiovascular or unknown causes. While it couldn't definitively conclude that Gilenya was related to any of the deaths, the FDA said it has concerns about the cardiovascular effects of the drug after the first dose. The data analysis showed that even though the maximum heart rate-lowering effect of the drug usually occurs ... Read more

Related support groups: Multiple Sclerosis, Gilenya, Fingolimod

Pot Might Help Ease Multiple Sclerosis Symptoms

Posted 14 May 2012 by Drugs.com

MONDAY, May 14 – Smoking pot can help relieve muscle tightness, called spasticity, and pain in people with multiple sclerosis, a new, small study suggests. "Spasticity is a major problem [in multiple sclerosis]," explained study author Dr. Jody Corey-Bloom, director of the University of California, San Diego Multiple Sclerosis Center. "People get very tight and it hurts, it feels like charley horses." Medicines are available, but they don't help everyone, she added. In the study, Corey-Bloom and her colleagues looked at 30 multiple sclerosis patients with muscle tightness who weren't helped by conventional medicines, and discovered they found relief by smoking pot. "Smoking pot reduces the spasticity by about a third compared to patients on [an inactive] placebo," she said. The study is published in the May 14 issue of the CMAJ (Canadian Medical Association Journal). More than 400,000 ... Read more

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FDA Issues Warning on Controversial MS Treatment

Posted 10 May 2012 by Drugs.com

THURSDAY, May 10 – Doctors and patients need to be aware of the potential risk of injuries and death associated with an experimental treatment for multiple sclerosis called liberation therapy, the U.S. Food and Drug Administration said in an alert issued Thursday. Liberation therapy is used to treat chronic cerebrospinal venous insufficiency (CCSVI) – a narrowing of veins in the neck and chest – believed by some to cause multiple sclerosis (MS) or worsen the disease. They think it does so by impairing blood drainage from the brain and upper spinal cord. The controversial procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. But the FDA has not approved this treatment for chronic cerebrospinal venous insufficiency, and the agency said it has learned of deaths, strokes, damage to the treated vein, blood clots, cranial nerve damage, ... Read more

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