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Diastat AcuDial (diazepam rectal gel)

Audience: Neurologists, pharmacists and consumers

[Posted 03/30/2006] Valeant Pharmaceuticals International and FDA notified healthcare professionals of complaints the company received concerning small cracks at the base of the plastic tip of the applicators with resulting leakage of the medication when the plunger is depressed, preventing full dosing and potentially resulting in a sub-optimal therapeutic response. Diastat is indicated for rectal administration in the management of selected refractory patients with epilepsy on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity. Complaints were received for the Diastat AcuDial Applicators 10mg and 20mg product twin packs.

Healthcare professionals should advise patients using the product of this issue and to return any product with a cracked tip to their pharmacy for immediate replacement. Pharmacists should inspect all product on their shelves and contact Rx Hope at 1-800-511-2120 or for replacement product. Emergency support should always be available in case seizures are not controllable with Diastat AcuDial.

[March 30, 2006 - Drug Information Page - FDA]
[February 21, 2006 - Dear Doctor Letter - Valeant]
[February 21, 2006 - Dear Pharmacist Letter - Valeant]