Health Product InfoWatch – April 2018
Organization: Health Canada
Date published: 2018-04-25
- Health products mentioned in this issue
- Monthly recap
- New information
- Helpful links
Health products mentioned in this issue
Pharmaceuticals and Biologics
- Alysena 21 and 28 (levonorgestrel and ethinyl estradiol)
- Cardizem CD (diltiazem hydrochloride)
- Fibristal (ulipristal acetate)
- Halaven (eribulin mesylate)
- Sodium Chloride Injection 0.9%, 250 mL
- Zinbryta (daclizumab beta)
Natural Health Products
Monthly recap of health product safety information
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.
"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.
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.
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.
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.
"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.
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.
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.
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.
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.
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.
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