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FDA's Advisory Panel Warns Users Of Diastat AcuDial Delivery Systems
The Food and Drug Administration is advising patients with epilepsy and their care givers 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. Caregivers for these patients are advised to call their local emergency response center or 911 for help in any seizure emergency.
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. The drug is typically administered by family members or caregivers at home.
"FDA is working with the manufacturer to resolve this issue as quickly as possible, as this is the only product approved to treat patients with this condition at home," said Dr. Steven K. Galson, Director of FDA's Center for Drug Evaluation and Research (CDER). "However, with routine inspection of the product, patients will be able to get the correct dosage administered for treatment."
Patients and their caregivers should immediately and carefully examine their Diastat AcuDial pre-filled syringes for cracks in the applicator tip, which can be easily seen. These inspections should be performed at least once a month. It is very important that the CAP NOT BE REMOVED during inspection. If you do not have internet access, or if you would like more advice regarding the inspection, call Valeant Pharmaceuticals at 1-877-361-2719.
Syringes with cracks should be returned to the pharmacist and exchanged for new ones at no cost. There have been more than 100 reports of cracked applicator tips in the 10mg and 20mg syringes. The frequency of cracks has varied, but as many as six percent of syringes in some lots have shown cracks.
The manufacturer, Valeant Pharmaceuticals of Costa Mesa, CA, has sent letters to pharmacists asking them to inspect the product prior to dispensing, and inform patients about the need to routinely inspect the syringes. The manufacturer has sent similar letters to physicians who treat patients with epilepsy.
The manufacturer believes that it has identified the source of the defects, but its new version of this product will not reach the market until June or July. Until then, current syringes will continue to be sold because there are no other available treatments for this condition that can be administered at home.
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