FDAnews Device Daily Bulletin

FDA ADVISORY: DIASTAT ACUDIAL DELIVERY SYSTEMS

April 5, 2006
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The FDA has issued an advisory to patients with epilepsy and their caregivers of a potential hazard caused by cracks in the applicator tips of Diastat AcuDial (diazepam rectal gel) delivery systems. These cracks can result in the leakage of gel during its application, which results in the patient not getting enough of the medicine to control seizures, the FDA said.

Diastat AcuDial pre-filled syringes are designed to deliver diazepam gel rectally in patients with acute repetitive seizures, a condition that, if inadequately treated, can progress to a life-threatening condition in which seizures are continuous. For directions on how to look for cracks on the applicator tip without removing the cap visit www.diastat.com (http://www.diastat.com).