Clinical trials which involving some patients taking the actual drug and others a placebo showed Aptiom was effective in reducing the frequency of seizures.
“Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments,” said Eric Bastings, M.D., acting director of the Division of Neurology at the FDA.
The drug's side effects included suicidal thoughts or actions in a very small number of people, like other antiepileptic drugs. Other side effects may include new or worsened anxiety or depression, or other behavior and mood changes.
The most common side effects reported in trials included dizziness, drowsiness, nausea, headache, double-vision, vomiting, fatigue and loss of coordination.
Aptiom has been approved for use in treating partial seizures, the most common form of epileptic seizure. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness.
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