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Related terms: Complex Partial Seizure, Fits, Absence Seizure

FDA Medwatch Alert: Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container

Posted 7 Jan 2016 by Drugs.com

ISSUE: Hospira, Inc. announced a voluntary recall of one lot of MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016) to the user level due to a confirmed customer report of an incorrect barcode on the primary bag labeling. The product has a barcode identifying the product contents on both the overwrap and on the primary container. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for HEPARIN SODIUM 2000 USP UNITS/1000 mL in 0.9% SODIUM CHLORIDE INJECTION. The product is labeled with the correct printed name on the primary container and overwrap. See the Press Release for product photos. If the incorrect barcode on Magnesium Sulfate in Water for Injection is not detected prior to dispensing or administration to a ... Read more

Related support groups: Seizures, Epsom Salt, Magnesium Sulfate, Sulfamag

Marijuana Chemical May Help Prevent Epileptic Seizures in Kids, Young Adults

Posted 25 Dec 2015 by Drugs.com

THURSDAY, Dec. 24, 2015 – A pill containing cannabidiol (CBD), a key ingredient in marijuana, may reduce seizures for children and young adults with epilepsy, new research suggests. However, the researchers and outside experts agreed that more investigation is needed before the treatment could be approved for patients. The finding stems from an investigation led by Dr. Orrin Devinsky, director of the Comprehensive Epilepsy Center at NYU Langone Medical Center in New York City. Conducted during 2014 and 2015, the study involved more than 200 patients at 11 epilepsy care centers across the United States. Patients were between the ages of 1 and 30, and all had been diagnosed with a form of treatment-resistant epilepsy. All were given CBD as a pill, starting at a dose of between 2-5 milligrams per kilogram (mg/kg) of body weight per day. Doses were gradually increased to a maximum of ... Read more

Related support groups: Seizures, Seizure Prevention, Cannabis, Seizure Prophylaxis

Genetic Abnormality May Explain Health Complications of Down Syndrome

Posted 14 Dec 2015 by Drugs.com

MONDAY, Dec. 14, 2015 – People with Down syndrome have long been known to face a higher risk for a range of other illnesses, including heart disease, diabetes and immune disorders. Now, a new study has honed in on a possible cause: too much of a specific gene that disturbs the peripheral nervous system. The peripheral nervous system is involved in basic organ-related activities. These activities include heartbeat, blood pressure and blood sugar levels, the Johns Hopkins University researchers explained. They looked at tissue samples from both mice and people with Down syndrome. They found that those with Down syndrome carry three times the normal amount of a certain gene called RCAN1. This particular gene helps regulate a protein known as "nerve growth factor." Excess amounts of RCAN1 lower the activity of nerve growth factor, the researchers observed. And that change led to impaired ... Read more

Related support groups: Diabetes, Type 2, Seizures, Heart Disease, Seizure Prevention, Diabetes, Type 1, Down Syndrome, Insulin Resistance, Autoimmune Disorders, Pre-Diabetes, Seizure Prophylaxis, Diabetes Mellitus, Ischemic Heart Disease, Abnormal Glucose Tolerance, Trisomy 18

Wearable Devices Aim to Monitor Epileptic Seizures

Posted 8 Dec 2015 by Drugs.com

TUESDAY, Dec. 8, 2015 – Wearable devices aimed at tracking seizures in epilepsy patients are being developed, researchers report. Three such devices – a patch, an arm band system and wrist-worn monitors – were reviewed in three separate studies and presented this week at an American Epilepsy Society meeting in Philadelphia. They do not yet have U.S. Food and Drug Administration approval as medical devices for recording seizures. However, their success could be very helpful to neurologists treating patients with epilepsy, said Dr. Clifford Segil, a neurologist at Providence Saint John's Health Center in Santa Monica, Calif. Segil was not involved in the research. "Wearable technology being used by neurologists is not as up-to-date as technology being used by cardiologists in 2015," Segil said. "Seizures are a very diverse group of disorders, which are not easily managed, and work ... Read more

Related support groups: Seizures, Epilepsy, Seizure Prevention, Seizure Prophylaxis, West Syndrome, Diagnosis and Investigation, Status Epilepticus, Lennox-Gastaut Syndrome, Seizure Prophylaxis During or Following Neurosurgery

Marijuana Chemical Shows Promise for Hard-to-Treat Epilepsy in Kids

Posted 7 Dec 2015 by Drugs.com

MONDAY, Dec. 7, 2015 – Evidence is mounting that a marijuana-derived oil might benefit some children with epilepsy whose seizures aren't controlled by approved medications, two new studies show. Cannabidiol (CBD) significantly reduced seizures in as many as half of children with epilepsy, researchers planned to report Monday at the American Epilepsy Society's annual meeting, in Philadelphia. But experts say these positive findings may have been influenced by a "placebo effect." All participants in these studies knew they were taking the oil, which could have affected reports of its effectiveness. "We know that our placebo rates can be as high as 30 percent, and sometimes higher," said Dr. Amy Brooks-Kayal, American Epilepsy Society president, who wasn't involved in the studies. "We don't know the real effect of the cannabidiol, and we won't until we complete the studies that are ... Read more

Related support groups: Seizures, Epilepsy, Seizure Prevention, Cannabis, Seizure Prophylaxis, West Syndrome, Status Epilepticus, Lennox-Gastaut Syndrome

Childhood Whooping Cough Tied to Small Rise in Epilepsy Risk

Posted 3 Nov 2015 by Drugs.com

TUESDAY, Nov. 3, 2015 – Whooping cough may be tied to a slightly increased risk for a young child to develop epilepsy, a new study finds. Whooping cough (pertussis) is relatively rare in the United States, however. And the absolute risk to any one child of getting epilepsy remains "low," said Dr. Meghan Fleming, a neurologist at Lenox Hill Hospital in New York City. She reviewed the findings from the new study. According to background information in the study, vaccination can prevent whooping cough, but roughly 16 million cases of the disease still occur worldwide each year. There were nearly 50,000 whooping cough cases reported in the United States in 2012, the study authors noted. In the new study, a team led by Dr. Morten Olsen of Aarhus University Hospital in Denmark looked at 4,700 Danish children with whooping cough. The children in the study were born between 1978 and 2011 and ... Read more

Related support groups: Seizures, Epilepsy, Seizure Prevention, Seizure Prophylaxis, Pertussis, Kinrix, Pertussis, Acellular, Diphtheria Toxoid/Pertussis, Acellular/Poliovirus Vaccine, Inactivated/Tetanus Toxoid, Daptacel (DTaP), Tripedia (DTaP), Vaccination and Prophlaxis, Pediarix, Boostrix (Tdap), Quadracel, Diphtheria Toxoid/Pertussis, Acellular/Tetanus Toxoid, Pentacel, Adacel (Tdap), Pertussis Prophylaxis, Tri-Immunol, Diphtheria And Tetanus Toxoids/Pertussis, Acellular

Gene May Boost Death Risk for People With Mild Epilepsy

Posted 23 Oct 2015 by Drugs.com

FRIDAY, Oct. 23, 2015 – Researchers say they've identified a gene mutation that might increase the risk of sudden death in people with mild epilepsy. The researchers studied a four-generation family with nine members who had epilepsy caused by a mutation of the DEPDC5 gene. This form of epilepsy is considered mild. But, two of the family members suffered what is known as sudden unexpected death in epilepsy (SUDEP), which is statistically significant for the small number of people in the study, according to the researchers in the Adult Genetic Epilepsy Program of the Krembil Neuroscience Center in Toronto. But the study did not prove that the gene mutation caused the increased risk for SUDEP. SUDEP is when a person with epilepsy who is otherwise healthy dies unexpectedly and without an apparent cause. About one in 1,000 people with epilepsy die of SUDEP each year, the researchers said. ... Read more

Related support groups: Seizures, Epilepsy, Diagnosis and Investigation

Could Marijuana Chemical Help Ease Epilepsy?

Posted 9 Sep 2015 by Drugs.com

WEDNESDAY, Sept. 9, 2015 – A chemical found in marijuana might help prevent epilepsy seizures, but drug laws have hampered research efforts, a new study says. Cannabidiol is one of the main active chemical compounds found in pot. But it doesn't make people high, the study authors said. Cannabidiol has already been shown to prevent seizures in animal studies and in one ongoing human trial, said lead author Dr. Daniel Friedman, a neurologist and epilepsy specialist at NYU Langone Medical Center in New York City. But legally, marijuana is considered a Schedule I controlled substance. That means the U.S. Drug Enforcement Agency classifies it as a drug with "no currently accepted medical use and a high potential for abuse." That classification makes it difficult to pursue large-scale trials that could prove cannabidiol's safety and effectiveness in epilepsy, Friedman said. "Right now, the ... Read more

Related support groups: Seizures, Epilepsy, Seizure Prevention, Cannabis, Seizure Prophylaxis, Status Epilepticus

Music Therapy Might One Day Help People With Epilepsy

Posted 9 Aug 2015 by Drugs.com

SUNDAY, Aug. 9, 2015 – Music therapy might someday help people with epilepsy, a new study suggests. About 80 percent of epilepsy patients have temporal lobe epilepsy, in which seizures originate in the temporal lobe of the brain. Music is processed in the auditory cortex, located in the same region of the brain, which is why researchers from Ohio State University's Wexner Medical Center wanted to study the connection. The study authors said that the brains of epilepsy patients appear to react to music differently from the brains of people without the disorder. "We believe that music could potentially be used as an intervention to help people with epilepsy," Christine Charyton, adjunct assistant professor and visiting assistant professor of neurology, said in an American Psychological Association (APA) news release. Charyton plans to present the research Sunday at the APA's annual ... Read more

Related support groups: Seizures, Epilepsy, Seizure Prevention, Seizure Prophylaxis, Status Epilepticus

FDA Approves Spritam (levetiracetam) as the First 3D Printed Drug Product

Posted 4 Aug 2015 by Drugs.com

BLUE ASH, Ohio, August 3, 2015 – Aprecia Pharmaceuticals Company today announced that the U.S. Food and Drug Administration (FDA) has approved Spritam (levetiracetam) for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.1 Spritam utilizes Aprecia's proprietary ZipDose® Technology platform, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid.1 While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA. “By combining 3DP technology with a highly-prescribed epilepsy treatment,2 Spritam is designed to fill a need for patients who st ... Read more

Related support groups: Seizures, Epilepsy, Levetiracetam, Spritam

FDA Approves First Pill Made by 3D Printing

Posted 4 Aug 2015 by Drugs.com

TUESDAY, Aug. 4, 2015 – The age of 3D printing has come to the drug industry, with the U.S. Food and Drug Administration on Monday approving the first pill made with the technology. The agency approved the prescription drug Spritam (levetiracetam) as a 3D-printed pill, to be taken with other medicines for seizures in certain children and adults with epilepsy. According to a news release from Ohio-based Aprecia Pharmaceuticals, the drug is made using a 3D printing method called ZipDose Technology, which produces a porous pill that rapidly disintegrates with a sip of liquid. 3D printing has already been used to make medical devices, but Spritam is the first 3D-printed drug to be approved for sale in the United States. It is expected to be available early next year. Experts say 3D printing of pills could usher in an era where drugs can be custom-ordered, based on specific patient needs, ... Read more

Related support groups: Seizures, Keppra, Seizure Prevention, Levetiracetam, Seizure Prophylaxis, Keppra XR, Elepsia XR, Spritam

Epilepsy Linked to Risks During Childbirth, Study Finds

Posted 6 Jul 2015 by Drugs.com

MONDAY, July 6, 2015 – Pregnant women with epilepsy may have more than a higher risk of dying during delivery, a new study suggests. "Specifically, there were 80 deaths per 100,000 women with epilepsy versus six deaths per 100,000 in women without epilepsy," said lead researcher Sarah MacDonald, from the department of epidemiology at Harvard T.H. Chan School of Public Health in Boston. However, although the so-called "relative risk" of death during delivery among women with epilepsy was high, it's still a rare occurrence, MacDonald stressed. The researchers also found that the risk of delivery complications was higher among women with epilepsy. "We also found that women with epilepsy were at increased risk for cesarean delivery, prolonged hospital stay, preeclampsia [pregnancy-related high blood pressure], preterm labor and stillbirth," she said. Although the study found a link between ... Read more

Related support groups: Seizures, Epilepsy, Seizure Prevention, Delivery, Seizure Prophylaxis, Labor Induction, Premature Labor, Labor and Delivery including Augmentation

FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures

Posted 30 Jun 2015 by Drugs.com

Tokyo, June 22, 2015 – Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. The FDA's decision to approve the indication expansion was based on a placebo-controlled clinical phase III study (Study 332) of Fycompa in 164 patients aged 12 years and older with PGTC seizures. In the study, a statistically significant reduction in PGTC seizure frequency was observed in the Fycompa group compared with placebo (Fycompa: -76.5%, placebo: -38.4%, p Read more

Related support groups: Seizures, Epilepsy, Seizure, Fycompa, Perampanel

Online Community Helps People Manage Epilepsy

Posted 17 Jun 2015 by Drugs.com

WEDNESDAY, June 17, 2015 – Being part of an online community may help people with epilepsy better manage their disease, a new study suggests. "Epilepsy is a complicated disease, and many people who live with it are not well informed about their condition and how to manage it. Formal, in-person education can be expensive and difficult to coordinate, especially when people live in rural areas. We wanted to see whether an online community could benefit people with epilepsy," study author Dr. John Hixson, of the University of California San Francisco and the San Francisco VA Medical Center, said in a news release from the journal Neurology. The research included almost 100 epilepsy patients who participated in an online forum called PatientsLikeMe. In the forum, people with epilepsy can share information and support. It also has digital tools for tracking seizures, symptoms and ... Read more

Related support groups: Seizures, Epilepsy, Seizure Prevention, Seizure Prophylaxis

FDA Medwatch Alert: Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration

Posted 16 Jun 2015 by Drugs.com

ISSUE: Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the FDA has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. To further explore any potential long-term consequences of these pigment changes, FDA has required the Potiga manufacturer, GlaxoSmithKline, to conduct a long-term observational study. FDA review of additional safety reports does not indicate that the pigment changes in the retina observed in some patients affect vision. Skin discoloration associated with the use of Potiga appears to be a cosmetic effect and does not appear to be associated with more serious adverse effects. Therefore, a modification of the Risk Evaluation and Mitigation Strategy (REMS) ... Read more

Related support groups: Seizures, Potiga, Ezogabine

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