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

Diazepam Rectal Gel is a Schedule IV controlled drug substance and should be administered no more frequently than every 5 days and no more than 5 times a month.
Diazepam Rectal gel is contraindicated in patients with acute narrow angle glaucoma.

Diazepam rectal gel should only be administered by caregivers who, in the opinion of the prescribing physician, (1) can identify the difference between cluster of seizures (and/or the events that precipitate the onset of seizures) from ordinary seizure activity, (2) are judged to be able to use product as instructed, (3) understand which seizures may or may not be treated with diazepam rectal gel, and (4) monitor the effect of diazepam rectal gel and know when to seek professional medical help.

Patients must be cautioned that diazepam rectal gel causes Central Nervous System (CNS) depression. Patients need to be advised against operating machinery, driving a motor vehicle, or riding a bike until they no longer feel the effects of the medication. Diazepam should not be used with alcohol or other CNS products that cause respiratory or CNS depressant effects. Prolonged CNS depression has been observed in neonates treated with diazepam; therefore diazepam rectal gel is not recommended for use in children under 6 months of age.

Because of general concerns about benzodiazepines, diazepam rectal gel should be used in pregnant women only after the physician considers the risk to the fetus.
Tonic status epilepticus has been precipitated in patients treated with IV diazepam for petit mal status or petit mal variant status.

Diazepam rectal gel should be used with caution in patients with compromised respiratory function, in patients with kidney or liver disease, in the elderly, and in nursing women. Although diazepam rectal gel is indicated only intermittently, the potential for synergistic CNS depressant effects and drug interactions should be considered.

The most frequent adverse event reported with the use of diazepam rectal gel in clinical trials was somnolence (23%). Less frequent adverse events reported (≤5%) were dizziness, headache, pain, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis.

Please see full DIASTAT AcuDial Prescribing Information.