IMPORTANT PRODUCT INFORMATION
Valeant Pharmaceuticals North America
Diastat® AcuDial™
Valeant Pharmaceuticals recently introduced new, more convenient dosing versions of Diastat, marketed as Diastat AcuDial. The company is now advising doctors, pharmacists and caregivers that small cracks have been found at the base of some plastic AcuDial applicators. According to the company, complaints concerning this issue “total less than 2% of all product produced since the launch of Diastat AcuDial.”
Attached are copies of each of the three company advisory letters which contain additional information and instructions for users of this product. Affiliates are urged to share this information with colleagues and patients, families or clients who should be aware of this issue.
Diastat AcuDial Caregiver Letter.pdf
| Diastat AcuDial Caregiver Letter |  |
March 15, 2006
IMPORTANT PRODUCT INFORMATION
Dear Caregiver,
This letter is to advise you that 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. Diastat AcuDial 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. The product is packaged as twin packs (two syringes in a package), with adjustable dosages set and locked by the pharmacist. 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 (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 and caregivers using this product should be told of this situation.
- Patients and caregivers are advised to inspect the Diastat AcuDial applicator as outlined in the attached instruction sheet.
- Any product with a cracked tip should be returned to the pharmacy for immediate replacement.
- Bring your Diastat AcuDial with you 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.
- Keep your current Diastat AcuDial in your 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 delivered cannot be verified with certainty.
- Patients and caregivers should also inspect the product for cracks periodically (i.e., monthly), 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. Please refer to Administration Instructions in the complete prescribing information for additional details. Patients and/or caregivers should also have a replacement product available for subsequent use, if clinically appropriate.
Should you have any additional questions, please contact Medical Information at 1-877-361-2719 or visit our website at www.diastat.com.
Sincerely,
Dr. Greg Kricorian
Director, Medical Affairs
Valeant Pharmaceuticals International
INSTRUCTION SHEET FOR INSPECTING DIASTAT ACUDIAL
Please follow these 4-step instructions to carefully inspect the Diastat Acudial for any crack. Be careful not to fully remove the cap from the syringe during inspection.
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| Step 1: Holding syringe in one hand with large end of oval pointing up and down. Place index finger in contact with cap to apply counter force when cap is opened. |
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| Step 2: Using the opposite hand grasp the cap firmly with your index finger, applying pressure to the seal pin to hold it in place. |
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