Cracked Tip Alert

Valeant Pharmaceuticals North America has received complaints of small cracks at the base of the plastic tip of some Diastat® AcuDial™ (diazepam rectal gel) syringes. The product comes as two syringes in a package. Complaints of cracks at the base of the plastic tip have been received for both the 10-mg and 20-mg product twin packs. We have not received any complaints on the 2.5-mg Diastat. The product may leak out from a crack when it is used, and the patient may not get all the medication. The skin may get pinched in the crack when used. Valeant is working to quickly fix this problem.

In the meantime:
  • You should inspect your DIASTAT AcuDial syringes immediately for any cracks, as described in the Inspection Instructions. DO NOT COMPLETELY REMOVE THE CAP DURING INSPECTION.

  • You should return any product with a crack in the tip to the pharmacy immediately for replacement. Bring your DIASTAT AcuDial with you to the Pharmacy for exchange.

  • Keep your current DIASTAT AcuDial with you until you get a replacement from your pharmacy.

  • If the seizure does not stop after you have given Diastat, then dial 911.

  • You should inspect DIASTAT AcuDial for cracks frequently, because cracks may appear over time, and immediately return any cracked syringes to your pharmacy for replacement.
If a decision is made to use DIASTAT AcuDial, you should have an emergency number nearby (i.e., 911 or ambulance), to be used if the seizure is not controlled. Please refer to the Administration Instructions that are included in the DIASTAT AcuDial package. You should also have extra Diastat AcuDial packages available for use in the future, if needed. Should you have any additional questions, please contact Medical Information at 1-877-361-2719

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IMPORTANT SAFETY INFORMATION

DIASTAT® AcuDial™ (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity for patients 2 years and older.

In clinical trials with DIASTAT®, the most frequent side effect was somnolence (23%). Less frequent adverse events reported were dizziness, headache, pain, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis (1%-5%). Please see full DIASTAT AcuDial Prescribing Information.