Updates to safety labelling for benzodiazepines and benzodiazepine-like drugs

Starting date:
October 30, 2020
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product label update
Audience:
General Public, Healthcare Professionals
Identification number:
RA-74223

Last updated:

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.  

OTTAWA – 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
  • 02232749
  • 02232751
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
  • 02247174
  • 02247176
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 - Clidinium bromide Capsule
  • 00618454
AA Pharma Inc.
LIBRAX Chlordiazepoxide hydrochloride - Clidinium 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
  • 02232657
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
  • 02232727
  • 02232732
Laboratoires Confab Inc.
OXPAM Oxazepam Tablet
  • 00414247
  • 00414255
  • 00414263
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
  • 01926799
Sanofi-Aventis Canada Inc.
SUBLINOX Zolpidem Tartrate Tablet
  • 02370433
  • 02391678
Bausch Health Canada Inc.
ZOLPIDEM TARTRATE ODT Zolpidem Tartrate Tablet
  • 02439646
  • 02439638
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
  • 00860697
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.

Media Enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public Enquiries

(613) 957-2991
1-866 225-0709