Health Product InfoWatch - November 2017

Contents

• Health products mentioned in this issue
• Monthly recap
• New health product safety information
  • Product monograph update
    • Clobex shampoo (clobetasol propionate solution 0.05% w/w)
• Scope
  • Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

• Pharmaceuticals and Biologics
  • Clobex shampoo (clobetasol propionate solution 0.05% w/w)
• Medical Devices
  • Paradigm insulin infusion pump
• Other
  • Foreign health products
  • Health products containing mannitol
  • 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 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.

• Foreign Product Alert (3 products)
• Foreign Product Alert (10 products)

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.

• Information Update - Health products containing mannitol

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.

• Summary Safety Review - Paradigm insulin infusion pump

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.

• Update - Sexual enhancement products