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MS 9 articles

Antipsychotic drugs considered as alternative treatment for MS

The antipsychotic drugs clozapine and risperidone may help improve symptoms in patients with multiple sclerosis, according to a study conducted by researchers with Victoria University of Wellington in New Zealand. Multiple sclerosis, or MS, is an autoimmune disease that affects the brain and spinal cord. It is unpredictable and often disabling, leading to impaired vision and coordination and paralysis. Medications approved to treat symptoms of the disease work through traditional immune pathways and don’t work on all populations of patients with MS. Researchers found that clozapine and risperidone target a very different set of pathways that work to reduce inflammation ... Read More

FDA rejects novel drug for multiple sclerosis, cites safety concerns

The Food and Drug Administration (FDA) has rejected Sanofi’s Genzyme unit’s bid for the multiple sclerosis (MS) drug alemtuzumab (Lemtrada), citing inadequate data and concerns about life threatening side effects. The drug company says it disagrees with the FDA’s decision and will appeal. MS is a debilitating autoimmune disease that affects the central nervous system, causing symptoms such as coordination problems and spasticity. Alemtuzumab is a novel treatment designed to down-regulate the inflammatory activity in MS. It is administered as an initial five-day course of infusions followed by a second three-day course a year later. The drug was pitted against beta-interferon, ... Read More

FDA issues alert about serious brain infection in patient taking MS drug

A patient treated with the multiple sclerosis (MS) drug Gilenya (fingolimod) has developed a rare and serious brain infection known as progressive multifocal leukoencephalopathy (PML), the Food and Drug Administration (FDA) warned. This is the first case of PML reported following the administration of Gilenya in a patient who had not previously received Tysabri (natalizumab), an MS drug that is associated with a higher risk of PML. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called the myelin. PML is usually leads to death or ... Read More

FDA warns of seizure risk with MS drug

Ampyra (dalfampridine), a drug used to help people with multiple sclerosis (MS) walk, has been linked to seizures, according to a recent safety announcement by the Food and Drug Administration (FDA). 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 also announced that it is updating the Ampyra drug label to clarify recommendations that kidney function should be checked in patients before starting the drug and be monitored at least annually while receiving Ampyra treatment. Additionally, patients who miss a dose should not take ... Read More

MS, Crohn’s drug linked to serious brain infections

The Food and Drug Administration (FDA) is alerting doctors and patients that Tysabri (natalizumab), a drug used to treat multiple sclerosis (MS) and Crohn’s disease, has been linked to a rare but serious brain infection known as progressive multifocal leukoencephalopathy (PML). The alert includes updated prescribing information about the risk for PML, and revised labeling that includes a table summarizing the rates of PML with Tysabri according to the number of infusions, or how long the drug is taken or the duration of exposure, and information on a newly identified PML risk factor. The new prescribing information and labeling informs ... Read More

FDA postpones decision to approve experimental MS treatment

The Food and Drug Administration (FDA) will take more time to decide whether to approve Merck KGaA’s Cladribine, an oral medication to treat relapsing forms of multiple sclerosis (MS). The agency had given the drug Priority Review status in July, which reduced the standard 10-month review process to six months. A decision was to have been made by Nov. 28, but the FDA voted to extend the review period in order to give a full review of additional information provided under the new drug application. If approved, Cladribine would be the first oral medication for MS. Cladribine was recently rejected ... Read More

MS, Crohn’s drug linked to numerous cases of serious brain infection

The Food and Drug Administration is updating health care professionals about a medication used to treat patients with relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn’s disease. New safety information indicates that the risk of developing a rare but life-threatening brain infection known as progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received of Tysabri (natalizumab). The announcement updates a September 2009 warning about PML associated with use of the Tysabri. Since 2006, Tysabri has only been available through the Tysabri Outreach Unified Commitment to Health, also known as the TOUCH Prescribing Program. The ... Read More

Rheumatoid Arthritis drug linked to serious neurological disorder

The Food and Drug Administration (FDA) has received a third case of a serious and often fatal neurological disorder known as progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis (RA) treated with the drug Rituxan (rituximab). The report has led the agency to inform rheumatological health care professionals that patients with RA who have received Rituxan are at an increased risk of PML. Physicians should consider the risks in any patient treated with Rituxan who presents new onset neurological manifestations. The FDA advises consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. ... Read More

Serious neurological disorder linked to MS, Crohn’s drug

A medication used to treat multiple sclerosis (MS) and Crohn’s disease has been linked to a serious and usually fatal neurological disorder, according to an alert issued to neurological health care professionals and their patients by the Food and Drug Administration (FDA). Natalizumab, marketed as Tysbri, was approved by the FDA in 2004 to treat relapsing forms of MS. In 2008, the FDA approved the drug’s use for moderately to severely active Crohn’s disease. From July 2006, when Tysabri marketing resumed, to September 8, 2009, there were 13 reported cases of Tysabri-related progressive multifocal leukoencephalopathy (PML) confirmed worldwide in patients ... Read More