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multiple sclerosis 12 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

Drug company hopes to win FDA approval for marijuana drug

British drug company GW Pharma is in advanced clinical trials for the world’s first drug made from raw marijuana as opposed to synthetic versions of the plant. The company hopes to gain approval from the Food and Drug Administration (FDA) by late 2013 for a mouth spray that treats cancer pain. The drug, called Sativex, contains delta 9-THC and cannabidiol, two main components of the marijuana plant. It has already been approved for use in Canada, New Zealand and eight European countries for relieving muscle spasms related to multiple sclerosis. The Drug Enforcement Agency considers marijuana a dangerous drug with ... Read More

FDA warns about illegal, dangerous stem cell products, procedures

Many people will do anything to find cures for deadly diseases. Some even travel to other countries, like Mexico, to have stem cell procedures that are not approved in the United States. But people should use caution because these medical procedures can be dangerous, the Food and Drug Administration (FDA) warns. In December 2011, three people were arrested in the United States and charged with 15 counts of criminal activity related to manufacturing, selling and using stem cells without FDA sanction or approval. According to the criminal indictment, one of the accused, a licensed midwife who operated a maternity care ... 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

Painkillers, diabetes drugs among most prescribed medications

The top 10 most prescribed drugs in America include pills to treat pain, diabetes, high cholesterol and high blood pressure, according to a report published this week by the IMS Institute for Healthcare Informatics. The best selling drug with more than 131 prescriptions dispensed was hydrocodone, the generic version of the painkiller Vicodin. The report also showed a new trend in prescription drugs. For the first time ever, less expensive generic drugs dominated brand name medications, making up 78 percent of all drugs sold in the United States in 2010. The cost savings in generics also drove down drug spending, ... 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