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FDA Medwatch Alert: Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches
Posted 19 days ago by Drugs.com
Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics ISSUE: FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly o ... Read more
Related support groups: Migraine, Seizures, Depakote, Migraine Prevention, Depakote ER, Migraine Prophylaxis, Divalproex Sodium, Valproic Acid, Depakote Sprinkles, Depakene, Stavzor, Depacon
FDA Warns Pregnant Women About Migraine Drugs
Posted 19 days ago by Drugs.com
MONDAY, May 6 – Pregnant women who struggle with migraine headaches should never use medicines containing the ingredient valproate because they can lower the IQ scores of their children, the U.S. Food and Drug Administration said Monday. The new warning will be included on the labels of medicines that contain valproate. These medicines already carry a boxed warning about fetal risk, including birth defects. Valproate products include valproate sodium (Depacon); divalproex sodium (Depakote, Depakote CP, and Depakote ER); valproic acid (Depakene and Stavzor); and their generic versions. "Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use," Dr. Russell Katz, director of the division of neurology products in the FDA's Center ... Read more
Related support groups: Migraine, Seizures, Valproic Acid, Depakene, Stavzor, Depacon
Implanted Device May Predict Epilepsy Seizures, Study Suggests
Posted 2 May 2013 by Drugs.com
THURSDAY, May 2 – An implanted device that monitors brain activity may offer a way to predict seizures in people with uncontrolled epilepsy, a small pilot study suggests. The findings, reported online May 2 in the journal Lancet Neurology, are based on only 15 patients, and the device worked far better in some than others. But experts said the results are promising, and should prompt further studies. "We just wanted to see if this is feasible, and this study shows that it is," said lead researcher Dr. Mark Cook, of the University of Melbourne and St. Vincent's Hospital in Australia. The prospect of being able to predict seizures is "very exciting," he said, in part because it's the uncertainty of the disorder that can dim people's quality of life. If people know a seizure is coming, Cook said, they can avoid driving or swimming that day, for example. They might also be able to adjust ... Read more
FDA Medwatch Alert: Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration
Posted 27 Apr 2013 by Drugs.com
ISSUE: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. FDA is working with the manufacturer to gather and evaluate all available information to better understand these events. FDA will update the public when more information is available. BACKGROUND: Potiga is approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older. The skin discoloration in the reported cases appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or toes, but more widespread involvement of the face and legs has also been reported. Scleral and conjunctival discoloration, on the white of the eye and ... Read more
Related support groups: Seizures, Seizure Prevention, Seizure Prophylaxis, Potiga, Ezogabine
Tapeworm-Linked Seizures May Be Rising in U.S., Doctors Say
Posted 8 Apr 2013 by Drugs.com
MONDAY, April 8 – Tapeworm infection in the brain that can trigger seizures is a growing health concern, doctors say. But the infection, which leads to swelling in the brain, is usually treatable with medication, according to a leading association of neurologists. Estimated cases of neurocysticercosis, as the tapeworm infection is called, range from 40,000 to 160,000 each year in the United States, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. "It's been around a long time, affecting people living in severe poverty, but the disease is not well-studied or understood," Hotez said. Texas is one area of the country with many cases. "The disease has now become a leading cause of epilepsy in Houston," Hotez said. "Every [week], we have patients come into our tropical medicine clinic with it." Concerns about an apparent ... Read more
Related support groups: Seizures, Neurocysticercosis
Lengthy Seizures May Delay Mental Development, Study Suggests
Posted 8 Apr 2013 by Drugs.com
MONDAY, April 8 – Delays in mental development are detectable in children within six weeks after they have a seizure that lasts more than 30 minutes, and these impairments are still present a year later, a new study finds. British researchers looked at 54 children, ages 1 to 42 months, who had at least one of these long seizures, called convulsive status epilepticus (CSE). Some of them had seizures with fever and some without fever. The children were assessed within six weeks of the seizure and again after one year. They were compared to children who had not suffered seizures. The findings suggest that convulsive status epilepticus is linked to neurodevelopmental delays within six weeks of the seizure, and that these impairments are still present after one year, according to the study published April 8 in the journal Epilepsia. "The fact that neurodevelopmental impairments are still ... Read more
Related support groups: Seizures
Study Supports Link Between Stress, Epileptic Seizures
Posted 4 Dec 2012 by Drugs.com
TUESDAY, Dec. 4 – Scientists have long thought that stress plays a role in epileptic seizures, and new evidence suggests that epilepsy patients who believe this is the case experience a different brain response when faced with a nerve-wracking situation. Researchers from the University of Cincinnati performed functional MRI brain scans during a stressful math exercise on 16 epilepsy patients who pegged stress as a factor in their seizure control and seven patients who did not. While both groups performed similarly on the test, those who perceived stress to have an impact on their epilepsy showed greater brain activation than the others during intimidating parts of the test. "One of the things we often hear is that a lot of epilepsy patients feel their seizures are affected by stress . . . but no one had really looked at their [brain response] or other elements of their physiological ... Read more
Related support groups: Anxiety and Stress, Seizures, Epilepsy
Children's Seizures Not Always Damaging, Study Finds
Posted 3 Dec 2012 by Drugs.com
MONDAY, Dec. 3 – Not all prolonged seizures permanently hurt children with epilepsy, according to preliminary findings from a long-term follow-up study. The study included 74 children with epilepsy who underwent an evaluation of brain health and mental skills within 10 years of initial enrollment. The tests showed that those who had experienced prolonged febrile seizures (convulsions triggered by a fever) were normal, the American and British researchers said. The study authors said they were surprised to discover that only one child had mesial temporal sclerosis, a type of brain damage that is most common in temporal lobe epilepsy. This suggests that the connection between febrile seizures and this condition is weaker than previously believed. The study was scheduled for presentation Monday at the annual meeting of the American Epilepsy Society in San Diego. "We have good reason to be ... Read more
Related support groups: Seizures
Antidepressants May Lead to Fewer Seizures in People With Epilepsy
Posted 3 Dec 2012 by Drugs.com
MONDAY, Dec. 3 – Besides helping to boost mood, antidepressants may also reduce seizure frequency for people with epilepsy, a new study suggests. The study, to be presented Monday at the annual meeting of the American Epilepsy Society in San Diego, included patients who were prescribed one of two types of antidepressants – selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). These types include drugs such as Celexa, Paxil, Prozac and Zoloft, among others. Researchers led by Dr. Ramses Ribot, of Rush University Medical Center in Chicago, tracked changes in mood and anxiety levels for 100 people with epilepsy at three and six months after the start of antidepressant therapy. Improvement or remission of symptoms was seen in 86 percent of patients, the investigators found. The antidepressants tested "do not appear to worsen seizure ... Read more
Related support groups: Lexapro, Zoloft, Seizures, Prozac, Celexa, Paxil, Citalopram, Epilepsy, Sertraline, Fluoxetine, Seizure Prevention, Paroxetine, Escitalopram, Luvox, Paxil CR, Fluvoxamine, Seizure Prophylaxis, Sarafem, Luvox CR, Pexeva
FDA Approves Fycompa to Treat Seizures
Posted 23 Oct 2012 by Drugs.com
October 23, 2012 – The U.S. Food and Drug Administration today approved Fycompa (perampanel) tablets to treat partial onset seizures in patients with epilepsy ages 12 years and older. Partial seizures are the most common type of seizure seen in people with epilepsy. Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. Seizures cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, and generalized convulsions with loss of consciousness. “Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It i ... Read more
Mouse Study Sheds Light on How Diet May Affect Epilepsy
Posted 23 May 2012 by Drugs.com
WEDNESDAY, May 23 – It's long been known that a high-fat, low-carbohydrate diet can reduce epileptic seizures that resist drug therapy, and now researchers studying mice say they think they know why. The results of their research in mice suggest that resistance to seizures among people who eat what's called a ketogenic diet is linked to a protein that modifies cellular metabolism in the brain. The findings, reported in the May 24 issue of the journal Neuron, may lead to the development of new treatments for epilepsy, according to the researchers at Dana-Farber Cancer Institute and Harvard Medical School in Boston. "The connection between metabolism and epilepsy has been such a puzzle," study co-leader Gary Yellen, a professor of neurobiology at Harvard Medical School, said in a Harvard news release. "I've met a lot of kids whose lives are completely changed by this diet. It's amazingly ... Read more
Response to First Treatment May Predict Epilepsy's Course
Posted 9 May 2012 by Drugs.com
WEDNESDAY, May 9 – The way someone responds to the first anti-seizure medication given after a diagnosis of epilepsy often predicts how well- controlled their seizures will be over time. A new study found that about 50 percent of people became seizure-free after the first medication they took. By contrast, only 13 percent became seizure-free after the second drug was tried, and just 4 percent were seizure-free after a third drug was tried. "The long-term treatment outcome is fairly constant, and thus predictable early on, in most people with epilepsy," said the study's lead author, Dr. Patrick Kwan, a professor of neurology at the University of Melbourne, in Australia. "Few patients become seizure-free after failure of the first two medications tried," he added. Results of the study are published in the May 9 online issue of the journal Neurology. Epilepsy is a seizure disorder. You ... Read more
Related support groups: Seizures, Epilepsy, Seizure Prevention, Seizure Prophylaxis
Epilepsy Leads to More Brain Abnormalities Over Time
Posted 3 Apr 2012 by Drugs.com
TUESDAY, April 3 – Aging accelerates brain-structure abnormalities in people with childhood-onset temporal-lobe epilepsy, a new study says. Temporal-lobe epilepsy is the most common type of partial epilepsy, with about 60 percent of all epilepsy patients having this form of the disease. Previous research suggests that people with childhood-onset epilepsy have significant mental and developmental problems that continue into adulthood, particularly in those who don't respond to seizure medications. Prior studies also have found that patients with temporal-lobe epilepsy have structural abnormalities in many areas of the brain. But there is limited knowledge about how aging affects these abnormalities. In the study, researchers from the University of Wisconsin-Madison used MRI to examine the brains of 55 patients with chronic temporal-lobe epilepsy and 53 people without epilepsy. The ... Read more
'Autoinjector' Offers Safe, Speedy Care for Life-Threatening Seizures: Study
Posted 15 Feb 2012 by Drugs.com
WEDNESDAY, Feb. 15 – Using an autoinjector device to deliver anti-seizure drugs into muscle is a fast, safe and effective way to treat status epilepticus, a prolonged type of seizure that lasts longer than five minutes, researchers report. "This is a very important study for persons with epilepsy," said one outside expert, Dr. Jacqueline French, first vice president of the American Epilepsy Society. "Prolonged seizures and status epilepticus can lead to brain damage, prolonged hospitalization, and other serious harm. The earlier treatment is initiated, the greater the likelihood that the seizure activity can be aborted quickly, and harm can be avoided," she said. French, who is also professor of neurology at the Comprehensive Epilepsy Center at New York University Langone Medical Center, New York City, believes the study "will set a new standard for treatment by emergency teams, that ... Read more
Related support groups: Seizures, Ativan, Lorazepam, Versed, Midazolam, Status Epilepticus
Surgery Effective for Tough-to-Treat Epilepsy
Posted 7 Feb 2012 by Drugs.com
TUESDAY, Feb. 7 – Surgery can significantly improve seizure control and quality of life among people with epilepsy, according to a study stretching over 26 years. "This study may be the longest follow-up of epilepsy surgery patients in that it spans three decades, during which there were several eras of neuroimaging [brain-scanning] techniques," said Dr. Cynthia Harden, chief of the division of epilepsy and electroencephalography at the Cushing Neuroscience Institute, part of North Shore-LIJ Health System in Great Neck, N.Y. She was not involved in the study. The research team, led by Dr. Matthew Smyth with Washington University School of Medicine in St. Louis, argued that the findings could have an impact on the way the disease is treated. As reported Feb. 7 in the journal Epilepsia, they followed 361 patients who had epilepsy surgery over the course of 26 years to determine how the ... Read more
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