Health Product InfoWatch – April 2018

Contents

• Health products mentioned in this issue
• Monthly recap
• New information
  • Product monograph update: Cardizem CD (diltiazem hydrochloride)
  • Vaccine safety biannual summary: Report for January 1, 2017 to June 30, 2017
• Scope
  • Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

Pharmaceuticals and Biologics

• Alysena 21 and 28 (levonorgestrel and ethinyl estradiol)
• Cardizem CD (diltiazem hydrochloride)
• Clozapine
• Fibristal (ulipristal acetate)
• Halaven (eribulin mesylate)
• Sodium Chloride Injection 0.9%, 250 mL
• Zinbryta (daclizumab beta)

Medical Devices

• Omnipod Insulin Management System
• Ophthalmic Viscosurgical Devices
• SurgiWrap adhesion barrier film

Natural Health Products

• "Beyond Yourself Multi Athlete"
• "Leopard Miracle of Honey"

Other

Unauthorized health products

Monthly recap of health product safety information

The following is a list of health product advisories, type I recalls as well as summaries of completed safety reviews published in March 2018 by Health Canada.

Alysena 21 and 28 (levonorgestrel and ethinyl estradiol)

Further to a recent advisory about the recall of one lot of Alysena 28 because of chipped pills, Health Canada informed Canadians that all lots of both Alysena 21 and Alysena 28 may have chipped pills. Health Canada reminded women to always check their pills carefully before taking them.

Advisory - Alysena 21 and 28 (levonorgestrel and ethinyl estradiol)

"Beyond Yourself Multi Athlete"

"Beyond Yourself Multi Athlete" multivitamin sold in bulk was seized from several Shop Santé stores in Quebec because it may pose serious health risks. While this multivitamin is labelled as approved by Health Canada (NPN 80053503), the dosing instructions and brand name on the package do not match Health Canada's authorization. Consumers following the package instructions would be exposed to excessively high doses of vitamins A and K. Health Canada has suspended licence NPN 80053503.

Advisory - "Beyond Yourself Multi Athlete"

Clozapine

This safety review evaluated the risk of agranulocytosis associated with clozapine. Health Canada's review concluded that the monitoring measures in place for agranulocytosis are acceptable, but that the risk should still be monitored. Therefore, Health Canada has asked that the manufacturers of clozapine submit a report, in 2 years, of all the data collected related to the risk of agranulocytosis when clozapine is used.

Summary Safety Review – Clozapine

Fibristal (ulipristal acetate)

Health Canada will be conducting a safety review of Fibristal (ulipristal acetate). The Canadian product monograph for Fibristal was updated in January 2018 to advise of rare cases of liver injury, including serious liver impairment requiring liver transplants. Since then, additional information on this issue has become available. Interim information for healthcare professionals and patients is provided in the information update.

Information Update – Fibristal (ulipristal acetate)

Halaven (eribulin mesylate)

This safety review evaluated the risk of severe cutaneous adverse reactions (SCAR) associated with Halaven (eribulin mesylate). Health Canada's review concluded that there was not enough evidence to establish a direct link between the use of Halaven and the potential risk of SCAR. The current product monograph covers the potential risk of SCAR and no additional warnings are required.

Summary Safety Review – Halaven (eribulin mesylate)

"Leopard Miracle of Honey"

Two versions of the sexual enhancement product “Leopard Miracle of Honey” may pose serious health risks. Both versions are labelled as being approved by Health Canada, with NPN 80073650. Health Canada’s testing found that both versions of the product contain undeclared sildenafil. The product was not authorized to contain sildenafil. Health Canada seized the products from 2 Ontario convenience stores located in Woodbridge, ON, and suspended the product licence.

Advisory – "Leopard Miracle of Honey"

Omnipod Insulin Management System

This safety review evaluated the risk of device malfunctions associated with the Omnipod Insulin Management System. Health Canada's review concluded that there is no new safety risk for the Omnipod. The safety information for this medical device is appropriate at this time.

Summary Safety Review – Omnipod Insulin Management System

Ophthalmic Viscosurgical Devices

This safety review evaluated the risk of toxic anterior segment syndrome (TASS) associated with Ophthalmic Viscosurgical Devices (OVDs) manufactured by Alcon Laboratories. Health Canada's review of the available information could not establish a link. Health Canada reminds healthcare professionals about the importance of following the Instruction for Use manuals issued by the manufacturers of OVDs and encourages reporting of adverse incidents associated with the use of OVDs.

Summary Safety Review – Ophthalmic Viscosurgical Devices

Sodium Chloride Injection 0.9%, 250 mL

Baxter Corporation has recalled 0.9% Sodium Chloride Injection, 250 mL (W7I05C2) as there is a potential for leakage of the intravenous bag.

Drug recall - Sodium Chloride Injection 0.9%, 250 mL

SurgiWrap adhesion barrier film

This safety review evaluated the risk of foreign body reactions (FBRs) that may mimic the local re-appearance of cancer associated with SurgiWrap adhesion barrier film. Health Canada's review concluded that there is currently not enough evidence to establish a link. No Canadian reports of FBRs were found that describe this adverse incident. The safety information for this product is suitable at this time as the Instructions for Use manual already contains a warning that FBRs may occur. Healthcare professionals are encouraged to consider this potential risk for the management of patients with cancer when SurgiWrap is used.

Summary Safety Review – SurgiWrap adhesion barrier film

Unauthorized health products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.

• Advisory – "Multi-Vitamines"
• Advisory – Injectable products and unauthorized prescription drugs
• Advisory – Unauthorized injectable drugs and medical devices
• Update – Multiple unauthorized health products

Zinbryta (daclizumab beta)

Following reports of serious inflammatory brain disorders, including immune-mediated encephalitis and meningoencephalitis, the manufacturer has decided to voluntarily withdraw Zinbryta from the Canadian market. All treating healthcare professionals were advised to immediately contact patients in their care who have been prescribed Zinbryta, and to initiate alternative treatment options as soon as medically appropriate. Given Zinbryta's potential for liver injury, patients discontinuing the product should have serum transaminase levels and total bilirubin levels monitored monthly, for 6 months after receiving their last dose of Zinbryta. Healthcare professionals should inform their patients that adverse reactions may also occur up to 6 months after discontinuation and to contact their physician immediately if any new symptoms occur.

Health Professional Risk Communication – Zinbryta (daclizumab beta)