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. Media enquiries Public enquiries OTTAWA â Benzodiazepines and benzodiazepine-like prescription drugs (commonly referred to as "Z-drugs)âcommonly used to treat sleep and anxiety disorders, certain seizure disorders, and to help relax muscles or relieve muscle painâcan 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
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