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Check Diastat applicator before use.

The Food and Drug Administration advises patients with epilepsy and their caregivers to check the applicator tips of Diastat AcuDial (diazepam rectal gel) delivery systems for cracks that may result in patients not receiving enough medication to control seizures.

The prefilled syringes are designed to deliver diazepam gel rectally in patients with acute repetitive seizures, which if inadequately treated can progress to a life-threatening condition in which seizures are continuous. There have been more than 100 reports of cracked applicator tips in the 10-mg and 20-mg syringes.

The agency advises patients and caregivers to immediately and carefully examine the syringes for cracks in the applicator tip, which easily can be seen. The inspections should be performed at least once a month. It is very important that the cap not be removed during inspection. For detailed directions on how to look for cracks without removing the cap, go to and click on the Alert box or call the drug's manufacturer, Valeant Pharmaceuticals, at 877-361-2719.

Cracked syringes should be returned to the pharmacist and exchanged at no cost. The manufacturer has sent letters to pharmacists and physicians who treat patients with epilepsy, informing them of the problem. A new version of this product will not reach the market until June or July.

--Kerri Wachter with staff reports
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Author:Wachter, Kerri
Publication:Clinical Psychiatry News
Article Type:Brief article
Geographic Code:1USA
Date:Jul 1, 2006
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