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FDA ALERT [3/2006]
Cracks have been found in the applicator tips of the 10 and 20 mg Diastat AcuDial prefilled syringes.    Medicine can leak through the cracks.   If medicine leaks, there may not enough medicine to treat a seizure.

If you or someone in your care uses Diastat AcuDial, carefully check your pre-filled syringes for cracks.  You should check the syringes WITHOUT REMOVING THE CAP.   For instructions:  visit http://www.diastat.com and click on the “Alert” Box to see photos, or call Valeant Pharmaceuticals at 1-877-361-2719,  about how to check for cracks.

If you see a crack, use a different syringe. Take all cracked syringes back to the pharmacist and exchange them for new syringes.   Cracks can appear over time, so keep checking on your syringes to make sure you have good ones ready to use if needed.

If seizures continue after using Diastat, get emergency medical help right away by calling 911.

The company that makes Diastat AcuDial prefilled syringes is working to correct the problem, but new syringes will not be available until June or July.  Meanwhile, the old prefilled syringes will still be dispensed because there is no other product available to treat sudden increased seizures.

What Is Diastat AcuDial?

Diastat AcuDial is a rectal gel in a prefilled syringe used to stop attacks of sudden increased seizures in patients two years and older who take other seizure medicines regularly, but still have sudden increased seizures.

Who Should Not Be Treated With Diastat?

You should not be given Diastat if you have an eye disease called acute narrow angle glaucoma.

What Are The Risks?
The following are the major potential risks and side effects of Diastat therapy. However, this list is not complete.

• rash
• trouble breathing
• overexcitement
• hallucinating (seeing things or hearing voices that do not exist)
• rage
• impaired judgment, thinking, and motor control (Do not operate a car, bicycle, or dangerous machinery until you have fully recovered from a dose of Diastat.)

 Other side effects that may occur with Diastat include:

• drowsiness
• dizziness
• headache
• pain
• stomach pain
• nervousness
• flushing
• diarrhea
• feeling unsteady
• abnormal 'high' mood

What Should I Tell My Healthcare Professional?

Before you are given Diastat, tell your healthcare professional if you:

• have breathing problems
• kidney problems
• liver problems
• drink large amounts of alcohol
• are pregnant, plan to become pregnant, or are breast-feeding

Can Other Medicines Or Food Affect Diastat?

Diastat and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Some medicines may affect how Diastat works or Diastat may affect how your other medicines work.  Know the medicines you take. Keep a list of them with you to show your healthcare professional.

FDA ALERT [03/2006]:  Healthcare professionals, patients with repetitive seizures, and people who care for someone with acute repetitive seizures, should be aware of a manufacturing problem with diazepam rectal gel (Diastat AcuDial) prefilled syringes.  There have been over a hundred reports of cracked applicator tips in the 10 and 20 mg rectal syringes.  These cracks can let the medicine leak during delivery so that the patient may be under-dosed and not receive enough of the drug to control seizures.  Diastat AcuDial syringes should be examined for cracks at the base of the applicator tips before dispensing, and frequently at home.  It is important to examine the syringes WITHOUT REMOVING THE CAP, as shown at http://www.diastat.com (click on the “Alert” box to see photos).  Any cracked syringes should be taken back to the pharmacy and exchanged for new syringes.  In the event of a seizure in which the appropriate dose of Diastat AcuDial delivered cannot be verified with certainty, patients should be told to get emergency medical help immediately by calling 911.  The manufacturer is working to correct the problem, but new product will not be available until June or July.  Meanwhile, the current stock will remain on the market because there is no other product for home administration for patients with acute repetitive seizures. 

 

Considerations

Healthcare professionals should consider the following when prescribing or dispensing Diastat:
 

• Advise patients or their caregivers to look at their Diastat AcuDial syringes to see if the base of the applicator tip is cracked.
• Advise patients that the CAP SHOULD NOT BE REMOVED during inspection and refer patients to the website (www.diastat.com) or to the Valeant Pharmaceuticals information line at 1-877-361-2719 for specific inspection instructions.  
• If any cracks are observed, the syringes should be returned to the pharmacy and exchanged for new syringes.
• Even if no cracks are seen, the syringes should be re-inspected frequently (i.e., monthly) because cracks may appear over time.  
• The cracks can result in leakage of the drug product at the time of delivery and under-dosing of patients.  If acute repetitive seizures are not adequately treated, the patient may develop status epilepticus, a condition of life-threatening continuous seizures.

Data Summary

There have been over a hundred reports of cracked applicator tips in DIASTAT ACUDIAL (diazepam rectal gel) DELIVERY SYSTEMS manufactured by Valeant Pharmaceuticals of Costa Mesa, California.  The cracks have occurred in both the 10 mg and 20 mg syringes (but not the 2.5 mg syringes).

DIASTAT ACUDIAL DELIVERY SYSTEMS are pre-filled syringes containing diazepam. They are designed to deliver the drug rectally in patients with acute repetitive seizures, a condition that, if inadequately treated, can progress to status epilepticus, a life-threatening condition in which seizures are continuous. The drug is typically administered by family members or caregivers at home.

The frequency of cracks has varied, but as many as 6% of syringes in some lots have shown cracking. The manufacturer has sent letters to pharmacists directing them to inspect the product prior to dispensing, and telling them to inform patients about the need to inspect the syringes (the cracks are easily seen). The manufacturer has also sent letters to physicians who treat patients with epilepsy.

Valeant believes that they have identified the source of the manufacturing problem, but they will not have new product on the market until June or July.  Until then, the current product will continue to be sold because there are no other products available that can be administered at home to treat acute repetitive seizures

Date created: March 30, 2006