Advisory - Updates to safety labelling for benzodiazepines and benzodiazepine-like drugs

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, 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.

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SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709