Syringe Applicator Tips Questioned

Washington, D.C. — Health officials warn that 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.

The F-D-A says cracks in the applicator tips of Diastat Acu-Dial may allow some of the gel to leak when administered rectally to control acute repetitive seizures. There have been more than 100 reports of cracked applicator tips. The 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.

Valeant Pharmaceuticals of Costa Mesa has sent letters to pharmacists asking them to inspect the syringes before dispensing them. The F-D-A says 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.