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.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.