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UCB Announces BRIVIACT® (Brivaracetam) now Approved by FDA to Treat Partial-onset (Focal) Seizures in Pediatric Epilepsy Patients

BRIVIACT® (brivaracetam) CV oral formulations are approved as a monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures   – Approval provides pediatric epilepsy patients a treatment option which can be initiated at a therapeutic dose from day one   – Pediatric epilepsy is the most common, serious neurological disorder among children and young adults, thought to affect nearly 470,000 children in the U.S[1],[2]   – Indication comes less than 2 years after the launch of BRIVIACT in the U.S., building on existing adult monotherapy and adjunctive therapy indications, and broadening clinical application for UCB’s newest anti-epilepsy drug   UCB announced today that the U.S. Food and Drug Administration (FDA...

FDA Reports a Life-Threatening Immune Reaction to Lamotrigine: What You Should Know

A rare but life-threatening immune reaction in response to lamotrigine (Lamictal) requires prompt diagnosis and treatment, according to a recent alert from the U.S. Food and Drug Administration (FDA).   On April 25, the FDA issued what it calls a “drug safety communication” about the risk of a condition so rare that few neurologists have heard of it: hemophagocytic lymphohistiocytosis (HLH), a systematic immune reaction that can result in organ failure and death if not quickly treated.   Just eight such cases associated with lamotrigine, including one death, are known by the FDA to have occurred since the drug was first approved in 1994 as a treatment for epilepsy. Since then, it has also been approved for bipolar disorder, and is now increasingly prescribed off-label...

Antiepileptic drugs linked with an increased risk of Alzheimer’s and dementia, says research

According to a new study from the University of Eastern Finland and the German Center for Neurodegenerative Diseases, DZNE, antiepileptic drugs are associated with an increased risk of Alzheimer’s disease and dementia.   The clinical investigation, led by Heidi Taipale from the University of Eastern Finland, evaluated the data of nearly 100,000 individuals with dementia or Alzheimer’s disease (from Germany and Finland) to see if there was a link between continuous use of antiepileptics and these neurodegenerative diseases and compared it with controls.

Educational Attainment Down With In Utero Exposure to AEDs

Exposure to sodium valproate or a combination of antiepileptic drugs (AEDs) in utero is associated with worse attainment on national educational tests for 7-year-olds, according to a study published online March 26 in the Journal of Neurology, Neurosurgery & Psychiatry. Arron S. Lacey, from Swansea University Medical School in the United Kingdom, and colleagues identified children born to mothers with epilepsy and linked these children to their national attainment Key Stage 1 (KS1) tests in mathematics, language, and science at age 7. The children were compared with matched children born to mothers without epilepsy.

Medication Adherence Key to Epilepsy Treatment

In assessing the effectiveness of prescribed medication there is a strong emphasis on the ability of the patient to adhere to the regime recommended by the clinician. For individuals with epilepsy, adherence to medication is crucial in preventing or minimizing seizures and their cumulative impact on everyday life. Non-adherence to antiepileptic drugs (AEDs) can result in breakthrough seizures many months or years after a previous episode and can have serious repercussions on an individual’s perceived quality of life. Reasons for non-adherence are complex and multilayered. Patients can accidentally fail to adhere through forgetfulness, misunderstanding, or uncertainty about clinician’s recommendations, or intentionally due to their own expectations of treatment, side-effects, and lifestyle ...

Which commonly prescribed drug is more effective for infants with epilepsy?

Study to help clinicians select an initial treatment for infants with epilepsy:   Comparison of two of the most commonly prescribed drugs for infants with nonsyndromic epilepsy revealed that levetiracetam was more effective than phenobarbital, according a multicenter, observational study published in JAMA Pediatrics. After six months of single-drug treatment, 40 percent of infants who received levetiracetam met criteria for successful outcome – they did not require a second anti-epileptic drug to control their seizures and they became seizure-free within three months of starting treatment. Only 16 percent of infants treated with phenobarbital achieved the same outcome.   “This is the first study to provide evidence that may help clinicians select an initial treatment ...

New genetic test can predict adverse reactions to epilepsy drug

A study led by researchers at RCSI (Royal College of Surgeons in Ireland) has identified a new genetic test that can be used to predict if a patient with epilepsy will develop an adverse reaction to a common anti-epileptic drug. The finding will help inform doctors to prescribe the safest and most beneficial treatment for patients with epilepsy. The study is published in the current edition of the journal Neurology. The research has identified a genetic factor that can be used to predict whether a patient with epilepsy will develop a rash in reaction to a common anti-epileptic drug called phenytoin. Phenytoin is used worldwide and is the most commonly prescribed anti-epileptic drug in developing countries.

More Than a Third of Patients Do Not Respond to Antiepileptics

More than one-third of patients with newly diagnosed epilepsy do not respond to treatment with antiepileptic drugs (AEDs), according to a study published online Dec. 26 in JAMA Neurology.   Zhibin Chen, PhD, from the University of Melbourne in Australia, and colleagues conducted a longitudinal observational cohort study to assess long-term outcomes in 1,795 patients with newly diagnosed and treated epilepsy. Patients were followed for a minimum of two years or until death.

High dose of Topiramate during pregnancy can up the risk of cleft lip or cleft palate in babies

The risk was higher when the mother took high doses of the drug than when she took lower doses.   A study says a higher dose of topiramate drug during the first tri-semester of pregnancy may up the risk of cleft lip or cleft palate more than when taking a lower dose. Topiramate is prescribed to prevent seizures in people with epilepsy. It is also used to prevent migraine headaches or treat bipolar disorder. In combination with phentermine, it may be prescribed for weight loss. “While topiramate is not recommended for pregnant women, unplanned pregnancies are common, so it’s important to fully examine any possible risk,” said Sonia Hernandez-Diaz, from the Harvard T.H. Chan School of Public Health in Boston. Adding, “Our study found that when pregnant women took topiramate during the f...

Is Lamotrigine Safe in Pregnancy?

Researchers evaluated the safety of the anti-epileptic medication, lamotrigine use during pregnancy on newborns and child development.   Most of the current evidence on antiepileptic drug (AED) use in pregnant women and the resulting increased incidence of child malformation and neurodevelopmental delay refers to the older generation of AEDs. Lamotrigine is a newer generation AED that is effective in treating a wide range of epileptic disorders and is generally well-tolerated and safe. Since there is currently no consensus on lamotrigine use in pregnancy and its impact on child malformations and neurodevelopment, researchers recently evaluated the impact of lamotrigine in children who were exposed to the drug in utero, that is, before birth.

Scientists developing a pharmaceutical that stops convulsions

Scientists from RUDN University took an active part in the development of a chemical compound to stop convulsions during epileptic seizures. The results of the study were published in Chirality.   Epilepsy is a chronic neuralgic disease that causes convulsive seizures in humans and other animals. The pathogenesis of this disease is paroxysmal discharges in the nerve cells of the brain that cause convulsions. Anticonvulsants help to stop the epileptic fit. The drug itself is a powder that is dissolved in water and injected into a person experiencing such a seizure.

FDA Approves Oral Lacosamide (Vimpat) for Children With Epilepsy

The US Food and Drug Administration (FDA) has approved use of the antiepileptic drug lacosamide (Vimpat, UCB) in tablets and oral solution (not intravenous injection) in children as young as 4 years with partial-onset seizures (POS), the company has announced. The FDA approved lacosamide in 2009 as adjunctive therapy and 2014 as monotherapy for adults with POS.   The expanded FDA indication for lacosamide as monotherapy and adjunctive therapy in children from age 4 years is based on the principle of extrapolation of its efficacy data from adults to children and is supported by safety and pharmacokinetics data collected in children, the company said in a news release. Adverse reactions in pediatric patients are similar to those seen in adult patients, they note.

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