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IMPORTANT PRODUCT INFORMATION

Valeant Pharmaceuticals North America has received complaints concerning small cracks at the base of the plastic tip of some Diastat® AcuDial™ (diazepam rectal gel) applicators.



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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 AcuDial (diazepam rectal gel) delivery system.

There is evidence that the product may leak out from these cracks when the plunger is depressed, possibly preventing full dosing and potentially resulting in a sub-optimal therapeutic response. There is also a risk that skin may get pinched in the crack during product insertion and administration.

Valeant is working diligently and quickly to resolve this situation.

In the interim:
  • Patients using this product should be told of this situation.
  • Patients should be advised to inspect the DIASTAT AcuDial applicator as outlined in the attached instruction sheet.
  • Patients who have product with a cracked tip should be advised to return to their pharmacy for immediate replacement.
  • Patients should bring their DIASTAT AcuDial with them to the Pharmacy for exchange.
  • Pharmacists should be instructed to contact Rx Hope at 1-800-511-2120 or www.Rxhope.com for replacement product.
  • Patients should be instructed to keep their current DIASTAT AcuDial in their possession until a replacement is available through the pharmacy. For any potential seizure emergencies that may arise, immediately dial 911 in the event of a seizure in which the appropriate dose of DIASTAT AcuDial delivered cannot be verified with certainty.
  • Patients should also periodically inspect the product for cracks and immediately return damaged syringes to their pharmacy and exchange those units which have a cracked applicator tip.

As is the case with any patient with epilepsy, emergency support should always be readily available in case seizures are not controllable with DIASTAT AcuDial.

There are no other substitute medications currently available that are FDA approved for at-home therapy to control bouts of increased seizure activity.

As stated in the prescribing information, if a decision is made to use DIASTAT AcuDial, patients should have an emergency number nearby (i.e. 911 or ambulance), to be utilized if appropriate therapeutic response is not achieved.

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.