Benzodiazepines and benzodiazepine-like prescription drugs used to treat sleep and anxiety disorders, certain seizure disorders, and to help relax muscles or relieve muscle spasms.
OTTAWA, ON, Oct. 30, 2020 /CNW/ -
Summary
Product: Benzodiazepines and benzodiazepine-like prescription drugs used to treat sleep and anxiety disorders, certain seizure disorders, and to help relax muscles or relieve muscle spasms.
Issue: Health Canada is working with Market Authorization Holders to update the safety labelling for these drugs to provide patients and healthcare professionals with prominent and consistent messaging about the severe and potentially life-threatening risks associated with these drugs.
What to do: Patients should discuss any questions or concerns about this safety information with their healthcare professional.
Benzodiazepines and benzodiazepine-like prescription drugs (commonly referred to as “Z-drugs)—commonly used to treat sleep and anxiety disorders, certain seizure disorders, and to help relax muscles or relieve muscle pain—can lead to problematic use and substance use disorder. To help mitigate these risks, Health Canada is asking manufacturers to update their safety warnings to include more prominent and consistent messaging for patients and healthcare professionals.
The update requested by Health Canada includes language around the risks of:
- problematic use and substance use disorder;
- severe withdrawal symptoms;
- harm when taken with opioids, which may cause deep drowsiness, respiratory depression, coma and death; and
- falls and fractures in specified populations.
The update includes labelling to reflect that problematic use of these medications can result in overdose or death, especially when combined with other medicines.
The update also contains information to address the risk of severe and life-threatening withdrawal symptoms that can result from abrupt discontinuation or rapid dose reduction.
The Government of Canada is committed to a broad range of activities to help address Canada’s opioid crisis in the areas of prevention, treatment, harm reduction, and enforcement. As part of this commitment, Health Canada is working to strengthen the labelling of benzodiazepines and benzodiazepine-like drugs to better reflect the serious risks when used with opioid drugs.
Impacted Products
| Product Name | Active Ingredient(s) | Formulation | DIN | Company |
| RIVOTRIL 0.5 TAB RIVOTRIL 2.0 TAB | Clonazepam | Tablet | 00382825, 00382841 | Hoffman-La Roche Limited |
| DIASTAT | Diazepam | Gel | 02238162 | Valeant Pharmaceuticals North America Llc. |
| DIAZEPAM 2MG TABLETS, DIAZEPAM 5MG TABLETS, DIAZEPAM 10MG TABLETS | Diazepam | Tablet | 02232737, | Laboratoires Confab Inc. |
| DIAZEPAM INJECTION USP | Diazepam | Solution | 00399728 | Sandoz Canada Inc. |
| VALIUM 5.0 TAB | Diazepam | Tablet | 00013285 | Hoffman-La Roche Limited |
| BIO-DIAZEPAM | Diazepam | Tablet | 02247173, | Biomed Pharma |
| ATIVAN | Lorazepam | Tablet | 02041413, 02041421, 02041448, 02041456, 02041464, 02041472 | Pfizer Canada Ulc. |
| LORAZEPAM INJECTION USP | Lorazepam | Solution | 02438704 | Sandoz Canada Inc. |
| XANAX, XANAX TAB 0.5MG, XANAX TAB 1MG, XANAX TS | Alprazoalm | Tablet | 00548359, 00548367, 00723770, 00813958 | Upjohn Canada Ulc. |
| CHLORDIAZEPOXIDE | Chlordiazepoxide hydrochloride | Capsule | 00522724, 00522988, 00522996 | AA Pharma Inc. |
| CHLORAX | Chlordiazepoxide hydrochloride - clinidium bromide | Capsule | 00618454 | AA Pharma Inc. |
| LIBRAX | Chlordiazepoxide hydrochloride - clinidium bromide | Capsule | 00115630 | Bausch Health Canada Inc. |
| APO-CLOBAZAM | Clobazam | Tablet | 02244638 | Apotex Inc. |
| FLURAZEPAM | Flurazepam HCl | Capsule | 00521698, 00521701 | AA Pharma Inc. |
| FLURAZEPAM 15MG CAP, FLURAZEPAM 30MG CAP | Flurazepam HCl | Capsule | 02232656, | Laboratoires Confab Inc. |
| SOM-PAM | Flurazepam HCl | Capsule | 00414220, 00414239 | Biomed Pharma |
| OXAZEPAM 10MG TAB, OXAZEPAM 15 MG TAB, OXAZEPAM 30MG TAB | Oxazepam | Tablet | 02232721, | Laboratoires Confab Inc. |
| OXPAM | Oxazepam | Tablet | 00414247, 00414255, | Biomed Pharma |
| MOGADON | Nitrazepam | Tablet | 00511528, 00511536 | AA Pharma Inc. |
| TRIAZOLAM | Triazolam | Tablet | 00808571 | AA Pharma Inc. |
| RESTORIL | Temazepam | Capsule | 00604453, 00604461 | AA Pharma Inc. |
| IMOVANE | Zopiclone | Tablet | 02216167, | Sanofi-Aventis Canada Inc. |
| SUBLINOX | Zolpidem Tartrate | Tablet | 02370433, 02391678 | Bausch Health Canada Inc. |
| ZOLPIDEM TARTRATE ODT | Zolpidem Tartrate | Tablet | 02439646, | Valeant Canada LP/Valeant Canada S.E.C. |
| STARNOC | Zaleplon | Capsule | 02297124,02297132 | Pfizer Canada Ulc. |
| LUNESTA | Eszopiclone | Tablet | 02453207, 02453215, 02453223 | Sunovion Pharmaceuticals Canada Inc. |
| TEVA-BROMAZEPAM | Bromazepam | Tablet | 02230584, 02230585 | Teva Canada Limited |
| CLORAZEPATE | Clorazepate dipotassium | Capsule | 00860689, 00860700, | AA Pharma Inc. |
| PMS-FLURAZEPAM CAP 15MG | Flurazepam HCl | Capsule | 00667102 | Pharmascience Inc |
| MIDAZOLAM INJECTION | Midazolam | Solution | 02240285, 02240286 | Sandoz Canada Incorporated |
| MIDAZOLAM INJECTION SDZ | Midazolam | Solution | 02382873, 02382903 | Sandoz Canada Incorporated |
What Health Canada is doing:
Health Canada is issuing specific instructions to all Market Authorization Holders (MAH) of the impacted products to request these updates.
Information for patients:
- Consult with your doctor or pharmacist if you have any questions or concerns regarding treatment with benzodiazepines or benzodiazepine-like drugs (commonly referred to as “Z-drugs”).
- Report any health product adverse events or health product complaint to Health Canada.
- Use benzodiazepines and all medicines exactly as prescribed by your healthcare professional.
- Store medications securely by keeping products in their original containers; in a cool, dry area, away from the sun; and out of the reach of children.
- Visit Health Canada’s website for information on benzodiazepines.
Information for healthcare professionals:
- Assess a patient’s condition, other medicines taken and the risk of problematic use and substance use disorder prior to prescribing.
- Reserve concomitant prescribing of benzodiazepines and opioids to patients for whom alternative treatment options are not possible.
- Limit dosages and durations to the minimum required.
- Monitor patients for signs and symptoms of respiratory depression and sedation.
- Avoid abrupt discontinuation or rapid dose reduction. Gradually taper to reduce the dose or to discontinue the medication.
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SOURCE Health Canada
