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Advisory: Diazepam Gel For Seizures

Diazepam Gel

The FDA is advising patients with epilepsy of a potential hazard caused by cracks in the applicator tips of diazepam rectal gel (Diastat AcuDial, Valeant). These cracks can result in the leakage of gel while it is being applied; this may cause patients to not get enough of the medication to control seizures.

The prefilled syringes are designed to deliver the gel rectally in patients with acute repetitive seizures. The drug is usually administered by family members or caregivers at home.
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At least once a month, patients and their caregivers should examine the syringes for cracks in the applicator tip. The cap should not be removed during inspection. Syringes with cracks should be returned to the pharmacist and exchanged for new ones at no cost.

A new version of this product is expected to be available in June or July. Until then, the current syringes are still being sold.

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