FDAnews Drug Daily Bulletin


April 10, 2006

Valeant Pharmaceuticals and the FDA have notified healthcare professionals about a defect in the applicator for the seizure treatment Diastat AcuDial (diazepam rectal gel).

"Complaints of cracks at the base of the plastic tip have been received for both the 10 mg and 20 mg product twin-packs," according to Valeant's recent Dear Doctor letter posted March 30 by the FDA. "We have not received any complaints on the 2.5 mg Diastat (diazepam rectal gel) delivery system," the company said. The cracks can result in leakage of the medication when the plunger is depressed, preventing full dosing and potentially resulting in a suboptimal therapeutic response, the FDA said.

Diastat AcuDial is indicated for rectal administration in the treatment of cluster seizures, also known as acute repetitive seizures.

Valeant said it is working diligently and quickly to resolve this situation. Healthcare professionals should alert patients using the product of the problem and advise them to return any product with a cracked tip to their pharmacy for immediate replacement, the FDA said.

For more information, access http://www.fda.gov/medwatch/safety/2006/safety06.htm#Diastat (http://www.fda.gov/medwatch/safety/2006/safety06.htm#Diastat).