FDA Issues Advisory for Epileptics Who Use Diastat AcuDial Delivery Systems

The Food and Drug Administration (FDA) is cautioning patients with epilepsy and their care givers of a possible hazard caused by cracks in the applicator tips of Diastat AcuDial (diazepam rectal gel) delivery systems.

The cracks can cause leakage during the application process thereby resulting in under-dosing of the drug, resulting in the patient not getting enough of the medicine to control seizures. Patients’ caregivers should call their local emergency response center or 911 for help in any seizure emergency.

Diastat AcuDial pre-filled syringes deliver diazepam gel rectally in patients with acute repetitive seizures. If inadequately treated, such seizures can progress to a life-threatening condition in which seizures are continuous.

“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 are advised to immediately and carefully examine their Diastat AcuDial pre-filled syringes for cracks in the applicator tip. The cracks can be seen easily. These inspections should be performed monthly, at the least. It is very important that patients and caregivers not remove the cap during inspection.

For detailed directions on how to inspect the products for cracks on the applicator tip without removing the cap go to www.diastat.com, and select the Alert box. You can also call Valeant Pharmaceuticals at 1-877-361-2719 for help or further information.

Cracked syringes should be returned to the pharmacist and exchanged for new ones free of charge.

To date, there have been more than 100 reports of cracked applicator tips in the 10mg and 20mg syringes. Overall, as many as six percent of syringes in some lots have shown cracks.

Valeant Pharmaceuticals of Costa Mesa, CA, manufacturer of the product, has sent letters to pharmacists asking them to inspect the product prior to dispensing, and inform patients about the need for routine inspections. The manufacturer has also sent letters to physicians who treat patients with epilepsy.

Valeant Pharmaceuticals believes that the source of the defects has been found, but the new version of this product will not be on the market until June or July. Therefore, current syringes will continue to be sold because there are no other treatment options available for this condition that can be given at home.

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