The FDA Issues a Public Health Advisory on Diastat AcuDial Diazepam Rectal Gel

Cracks in the applicator tips for DIASTAT AcuDial (diazepam rectal gel) delivery systems (made by Valeant Pharmaceuticals) have occurred.  Patients with epilepsy and their family members or caregivers should look carefully at their Diastat AcuDial pre-filled syringes immediately, as explained below.   The CAP MUST NOT BE REMOVED when looking for applicator cracks, and the directions on how to look for cracks must be followed carefully. These cracks can result in leakage of the drug product when it is given, so that the patient may not get enough of the medicine to control seizures.

If the product leaks when being given, or if the patient continues to have seizures, get emergency medical help right away by calling 911.

Patients or their caregivers should check syringes every month, without removing the cap, to see if the applicator tip is cracked. For directions on how to look for cracks on the applicator tip without removing the cap go to www.diastat.com, and click on the Alert box. If you do not have internet access, or if you would like some more help, contact Valeant Pharmaceuticals at 1-877-361-2719 about how to check your syringes for cracks. If any are cracked, the syringes should be returned to the pharmacist and exchanged for new syringes. Even if cracks are not visible, the syringes should be re-inspected frequently (every month) because cracks may appear over time.

The cracks have occurred in both the 10 mg and 20 mg syringes (but not the 2.5 mg syringes). DIASTAT AcuDial Deluvery Systems are pre-filled syringes containing diazepam. They are designed to deliver the drug rectally in patients with acute repetitive seizures, a condition that, if inadequately treated, can progress to status epilepticus, a life-threatening condition in which seizures are continuous. The drug is typically administered by family members or caregivers at home.

There have been over a hundred reports of cracked applicator tips in this product, DIASTAT AcuDial (diazepam rectal gel) Delivery Systems manufactured by Valeant Pharmaceuticals of Costa Mesa, California.  The frequency of cracks has varied, but as many as 6% of syringes in some lots have shown cracking. The manufacturer has sent letters to pharmacists directing them to inspect the product prior to dispensing, and telling them to inform patients about the need to inspect the syringes (the cracks are easily seen). The manufacturer has also sent letters to physicians who treat patients with epilepsy.

Valeant believes that they have identified the source of the manufacturing problem, but they will not have new product on the market until June or July.  Until then, current product will continue to be sold because there are no other available treatments for this condition that can be administered at home.