FDA Approves Toddler Use for Seizure Drug


The FDA extended the use of toparimate, an anti-seizure drug, to children as young as 2.

The US Food and Drug Administration (FDA) today approved the use of topiramate (Qudexy XR/Upsher-Smith) for children 2 and older who are experiencing partial-onset seizures or tonic-clonic seizures, the company announced.

The drug is already approved for children 10 and older. The drug is a capsule made in once-daily extended-release form.

The recommended way to give it to young children is sprinkling on soft food since children under 10 may have trouble swallowing capsules and tablets.

It is approved for initial monotherapy.

It is also approved as an adjunct therapy for patients with seizures associated with Lennox-Gastaut syndrome.

The drug has been available in the US since June 2014, the company noted.

Side effects include serious eye problems that can lead to permanent loss of vision if not treated, decreased sweating and fever, and metabolic acidosis.

Like other antiepileptic drugs, it can also cause depression and suicidal thoughts. The company said the symptoms occur in about 1 in 500 patients.

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