Health Product InfoWatch - June 2015

ISSN 2368-8025
Pub. no 140412

Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team

Contents

Health products mentioned in this issue

Pharmaceuticals and Biologics

Natural Health Product

Other

Scope

This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

Reporting Adverse Reactions
Canada Vigilance Program
Phone: 1-866-234-2345
Fax: 1-866-678-6789

For more information on how to report an adverse reaction, visit the Reporting Adverse Reactions to Drugs and Other Health Products page.

Monthly recap of health product safety information

The following is a list of health product advisories as well as summaries of completed safety reviews published in May 2015 by Health Canada.

Alveda Furosemide Injection (USP 10 mg/mL)

Alveda Pharmaceuticals Inc. recalled one lot (lot 30208) of Furosemide Injection USP 10 mg/mL which has the same barcode on its inner label as that of Alveda Epinephrine Injection USP 1 mg/mL. This could result in a serious medication error due to misidentification of either product leading to inadvertent administration of the wrong product.

Foreign Health Products

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients. The products are not authorized for sale in Canada and have not been found in the Canadian marketplace but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Galenic Health Ginger in Bentonite

Alliance Principle Ingredients/Neutrical Solutions Inc. recalled the natural health product Galenic Health Ginger in Bentonite (NPN 80053535) due to unacceptable levels of lead for adolescents and children. The product currently contains levels of lead beyond permitted limits for children, but within acceptable limits for adult dosing. Ginger in Bentonite is used to relieve digestive upset and disturbances.

NaturaLyte Sodium Bicarbonate Liquid Concentrate

Fresenius Medical Care voluntarily recalled specific lots of NaturaLyte Sodium Bicarbonate Liquid Concentrate (DIN 02230083) in 6.4 L and 8 L volumes due to possible bacterial contamination.

Nexavar (sorafenib)

This safety review evaluated the potential risk of drug-induced thyroid gland dysfunction associated with Nexavar (sorafenib). Health Canada concluded that there was evidence of thyroid gland disorders in association with Nexavar use. Health Canada has updated the Canadian prescribing information for Nexavar to inform healthcare professionals, caregivers and patients about the risks of thyroid dysfunction. Thyroid function monitoring should be considered before and during Nexavar use.

Prolia (denosumab)

This safety review evaluated the potential risk of cardiovascular adverse events associated with the use of Prolia (denosumab). The current available evidence does not support an association between Prolia and the risk of cardiovascular adverse events. In addition, the risk of hypocalcemia and its effects on heart rhythm (e.g., QT interval prolongation) is included in the Canadian prescribing information.

Sevorane AF (sevoflurane)

This safety review evaluated the potential risk of severe bradycardia with the use of the general anaesthetic sevoflurane (Sevorane AF and generics) in children with Down syndrome. Health Canada concluded that the risk of bradycardia with sevoflurane should be considered for all children. The prescribing information for sevoflurane mentions the risk of bradycardia in healthy children and in children with neuromuscular problems. This will now be updated to include the occurrence of cases of bradycardia in children with Down syndrome.

Stiff Rock

Health Canada testing found that the unauthorized health product "Stiff Rock" contains the undeclared drug ingredients sildenafil, aminotadalafil and hydroxythiohomosildenafil. The product, promoted for male sexual performance enhancement, was removed from sale from Boutique Érotique 5ieme avenue (also known as Boutique Érotique Liberté), in Valleyfield, QC.

Uloric (febuxostat)

This safety review evaluated the potential risk of agranulocytosis associated with Uloric (febuxostat). International cases of agranulocytosis suspected of being associated with the use of Uloric have been identified. Health Canada has not received any adverse reaction reports related to this issue. Health Canada has requested that the manufacturer submit information updates on the safety of Uloric which will be monitored and assessed.

Helpful links

Suggestions?

Your comments are important to us. Let us know what you think by reaching us at InfoWatch_InfoVigilance@hc-sc.gc.ca

Health Canada
Marketed Health Products Directorate
Address Locator 0701D
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Fax: 613-952-7738

Copyright

© 2015 Her Majesty the Queen in Right of Canada. This publication may be reproduced without permission provided the source is fully acknowledged. The use of this publication for advertising purposes is prohibited. Health Canada does not assume liability for the accuracy or authenticity of the information submitted in case reports.

Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.

Due to time constraints relating to the production of this publication, information published may not reflect the most current information.

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