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FDA Approves Aptiom (Eslicarbazepine) to Treat Seizures in Adults

Drug indicated as add-on therapy (November 8)

The FDA has approved Aptiom (eslicarbazepine acetate, Sunovion Pharmaceuticals) as an add-on medication to treat seizures associated with epilepsy.

The drug is approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior, and generalized convulsions with loss of consciousness. Seizures can have serious consequences, including injury and death.

Three clinical studies in which participants with partial epilepsy were randomly assigned to receive eslicarbazepine or placebo demonstrated that eslicarbazepine is effective in reducing the frequency of seizures.

The most common side effects reported by patients receiving eslicarbazepine in clinical trials included dizziness, drowsiness, nausea, headache, double vision, vomiting, fatigue, and loss of coordination.

Like other antiepileptic drugs, eslicarbazepine may cause suicidal thoughts or actions in a small number of patients.

Aptiom (eslicarbazepine) has been approved with a medication guide that provides patients with important information about the drug that can help patients avoid serious adverse events. The guide will be distributed each time a patient fills his or her prescription.

Source: FDA; November 8, 2013.

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