Health Product InfoWatch - November 2017

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

ISSN 2368-8025
Pub. no 160256

Contents

Health products mentioned in this issue

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 October 2017 by Health Canada.

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.

Health products containing mannitol

Health Canada is aware of recent concerns around the use of mannitol as a non-medicinal ingredient in medications for use by pregnant women. Based on Health Canada's evaluation of the evidence available to date, consumption of small quantities of sugar substitutes, including mannitol, during pregnancy does not pose a health risk.

Paradigm insulin infusion pump

This safety review evaluated the risk of device malfunctions associated with Paradigm insulin infusion pumps manufactured by Medtronic MiniMed. Health Canada performed a review to assess the effectiveness of changes to the pump following recommendations from a previous review. The current review identified additional issues relating to loose drive support caps, keypad problems and blank screens. These malfunctions may lead to the patient's blood sugar becoming too high or too low. Health Canada will monitor and reassess these issues in 2 years, including the actions taken by the manufacturer to address current issues.

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.

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