Health Product InfoWatch - December 2017

Contents

• Health products mentioned in this issue
• Monthly recap
• New health product safety information
  • Product monograph update: Eprex (epoetin alfa)
  • Product monograph update: Gilenya (fingolimod)
• Scope
  • Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

• Pharmaceuticals and Biologics
  • Eprex (epoetin alfa)
  • Fluconazole 150 mg
  • Gilenya (fingolimod)
  • Mifegymiso (mifepristone and misoprostol)
• Medical Devices
  • Breast implants
  • TactiCath Quartz
• Natural Health Products
  • Green tea extract-containing natural health products
• 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 November 2017 by Health Canada.

Breast implants

This safety review evaluated the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Health Canada's safety review determined that the rate of BIA-ALCL in Canada is low. Nearly all the cases were associated with implants that have a textured surface. Health Canada is working with manufacturers who will update the safety information on the product labelling for breast implants. In addition, Health Canada will actively monitor all reported Canadian cases of BIA-ALCL through a yearly follow-up with the manufacturers of breast implants. Health Canada has also communicated this information to healthcare professionals and the public.

• Summary Safety Review – Breast implants
• Health Professional Risk Communication – Breast implants
• Information Update – Breast implants

Fluconazole 150 mg (non-prescription)

This safety review evaluated the risk of unwanted effects in pregnancy including miscarriage, stillbirth and birth defects associated with non-prescription fluconazole (oral, 150 mg). Health Canada's review found that a link cannot be made at this time based on the currently available information. The manufacturer of Diflucan ONE voluntarily updated the Canadian product monograph about these potential risks. Health Canada concluded that the proposed update for Diflucan ONE is appropriate and has recommended that the Canadian product monograph for all other non-prescription fluconazole products be updated in the same way.

• Summary Safety Review – Fluconazole

Green tea extract-containing natural health products

This safety review evaluated the risk of hepatotoxicity associated with green tea extract-containing natural health products. Health Canada's review concluded that there may be a link, that cases of hepatotoxicity continue to be reported, and that Canadian safety information could be stronger. Health Canada is strengthening the safety information in its Green Tea Extracts monograph and is working with manufacturers to strengthen the safety information on labels of these products. The safety review also recommended that green tea extract-containing products be used by adults only (18 years and over). These new safety warnings will be updated on product labels. Health Canada has also communicated this information to healthcare professionals and the public.

• Summary Safety Review – Green tea extract-containing NHPs
• Health Professional Risk Communication – Green tea extract-containing NHPs
• Information Update – Green tea extract-containing NHPs

Mifegymiso (mifepristone and misoprostol)

Mifegymiso is now indicated for use up to nine weeks (63 days) into a pregnancy. Modifications have been made to the Mifegymiso product monograph and the Risk Management Plan. Changes have also been made to the Distribution and Education Program in Canada.

• Health Professional Risk Communication – Mifegymiso (mifepristone and misoprostol)
• Information Update – Mifegymiso (mifepristone and misoprostol)

TactiCath Quartz

This safety review evaluated the risk of cardiac tamponade associated with TactiCath Quartz. Health Canada's review of the available information concluded that there is a potential link. The risk is known and labelled in the Instructions for Use for TactiCath Quartz. Health Canada encourages healthcare professionals to follow the Instructions for Use given by the manufacturer when using this device to treat patients and to report any side effects associated with its use.

• Summary Safety Review – TactiCath Quartz

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 – E-Fong XuDuan Concentrated Herb Tea
• Advisory – Sexual enhancement products
• Update – Sexual enhancement products