FDA warns of cracks in home-use syringes for epileptic drug

Monday, April 3rd 2006, 11:51 am

By: News On 6

WASHINGTON (AP) _ Cracks in the tips of pre-filled plastic syringes used to administer a seizure-control medication may prevent epileptics from getting the full dose they need, health officials warned Monday.

The cracks in the applicator tips of Diastat AcuDial may allow some of the gel to leak when administered rectally to control acute repetitive seizures, the Food and Drug Administration said. There have been more than 100 reports of cracked applicator tips in the 10 mg and 20 mg syringes.

Diastat, or diazepam rectal gel, is the only product approved for the home treatment of patients with acute repetitive seizures. The drug is usually administered by caregivers or family members. The FDA recommended they call 911 if a patient's seizures continue after using the drug.

Patients and caregivers should examine the pre-filled syringes, without completely removing the applicator cap, once a month for cracks in the applicator tip. The cracks can be easily seen. Syringes with cracks should be returned to a pharmacy and exchanged at no cost.

There have been more than 100 reports of cracked applicator tips in the 10 mg and 20 mg syringes, with as many as six percent of syringes in some lots cracked.

Valeant Pharmaceuticals of Costa Mesa, Calif., has sent letters to pharmacists asking them to inspect the syringes before dispensing them. The company believes it has identified the source of the cracks, but will not be able to release a new version until June or July, the FDA said.

For more information go the Diastat Web site at: http://www.diastat.com or call (877) 361-2719.