US regulators announced Tuesday that the agency will require manufacturers of anti-epileptic drugs to add warnings on the labels about the risk of suicidality. In keeping with the recommendation of an FDA advisory panel in July, the labelling update will not involve a boxed warning.

The labelling update will indicate that about 1 in 500 patients [...]

Popularity: 14% [?]

Medical specialists at the nation’s largest professional meeting on epilepsy discussed multiple questions and concerns they have about data presented by the FDA in support of its recent suicide alert on anticonvulsant drugs (AEDs) and the potential effect of the federal agency’s analyses on clinical practice and the way AED drug trials are to be [...]

Popularity: 15% [?]

Studies Presented at American Epilepsy Society Annual Meeting
ATLANTA — UCB today announced findings from new studies of the once-daily antiepileptic drug (AED) Keppra XR(TM) (levetiracetam) extended-release tablets comparing tolerability versus levetiracetam immediate release (IR) and reporting on additional dosing schedules. The data were among five studies that were presented at the 62nd annual meeting of [...]

Popularity: 13% [?]

Trials showed Banzel proved effective against Lennox-Gastaut syndrome
A new drug called Banzel (rufinamide) has been approved as a supplementary treatment for a severe form of epilepsy called Lennox-Gastaut syndrome, the U.S. Food and Drug Administration announced Friday.

The approval was based on results of a four-month clinical trial that included patients ages 4 to 30. Compared [...]

Popularity: 15% [?]

A faulty immune reaction may be responsible for the development of epilepsy, research suggests.
Studies in mice by US and Italian researchers linked seizures to brain changes which made immune cells stick inside its blood vessels.

This, in turn, the journal Nature Medicine reported, helped break down a vital filter which protects the brain from harmful chemicals.
“Unsticking” [...]

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The nine families involved in the study all lived in the Middle East and came from one of three family lines. Of the 47 individuals in the three family lines, 23 had a form of progressive myoclonus epilepsy accompanied by ataxia — a condition that causes imbalance.

Popularity: 21% [?]

PITTSBURGH — Mylan Inc. (MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma’s Keppra(R).
Robert J. Coury, Mylan’s Vice [...]

Popularity: 25% [?]

Patients treated for their prolonged seizures with the sedative propofol may be at high risk for complications and even death. New research presented at CHEST 2008, the 74th annual international scientific assembly of the American College of Chest Physicians (ACCP), shows that the use of propofol as an antiepileptic agent in patients with refractory status [...]

Popularity: 36% [?]

Epilepsy is a chronic neurological disorder affecting approximately three million people in the U.S. Less than half (47%) will attain seizure control with their first AED, and more than 30% will continue to experience seizures despite trying two or more AEDs.

Popularity: 31% [?]

The filing is supported by data from three placebo-controlled clinical trials in patients with epilepsy. Results from the first study were presented at the Ninth EILAT Conference on Antiepileptic Drugs in June and results from two additional studies will be presented at the annual meeting of the American Epilepsy Society later this year.

Popularity: 49% [?]