Health Product InfoWatch – January 2018

Medical Devices

• Fentanyl-detection test strips

Other

• Foreign health products
• Unauthorized health products

Announcement

Consultation on naming of biologic drugs

Health Canada and the Institute for Safe Medication Practices Canada (ISMP Canada) are seeking input from healthcare providers, consumers, and other stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada. 

Results of the consultation will be used to:

• understand the impact of different proposed approaches to biologic drug naming and the perspectives of stakeholders, and
• inform Health Canada’s policy decision on a naming convention for biologic drugs.

The questionnaire and further details on this initiative can be accessed online from January 18 to February 9, 2018.

Please distribute this message to colleagues, members, or stakeholders to inform them of the consultation.

Access the questionnaire

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 December 2017 by Health Canada.

Alesse 21 and Alesse 28

Blister packages for Alesse 21 and Alesse 28 were found to contain one broken pink tablet in a sealed blister. Broken or split birth control tablets may deliver a smaller dose of the active drug ingredients. Healthcare professionals are advised to remind patients to check tablets before taking them and not consume tablets that are broken or split; return blister packages containing broken or split tablets to the pharmacy to get a replacement package; and seek counsel on the proper use of oral contraceptives, and on what to do if a dose is missed.

• Health Professional Risk Communication – Alesse 21 and Alesse 28
• Advisory – Alesse 21 and Alesse 28

Benzodiazepines and barbiturates

This safety review evaluated the risk of neurodevelopmental disorders associated with lorazepam, midazolam, phenobarbital and thiopental. Health Canada’s review of the available information concluded that there is limited evidence suggesting a link between the use of these sedative and anesthetic drugs and neurodevelopmental disorders. Health Canada will look into working with the Drug Safety and Effectiveness Network to further study the link between the use of sedative and anesthetic drugs and the development of the brain. Health Canada has also communicated this information to Canadians.

• Summary Safety Review – Benzodiazepines and barbiturates
• Information Update – Benzodiazepines and barbiturates

Fentanyl-detection test strips

Health Canada advised Canadians of the potential limitations when using test strips to detect fentanyl in street drugs. A preliminary study undertaken by Health Canada indicated that false negatives could occur when using fentanyl-detection test strips. A false negative could lead to a false sense of security which may result in overdose or death.

• Information Update – Fentanyl-detection test strips

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

Gilenya (fingolimod)

This safety review evaluated the risk of thrombocytopenia associated with Gilenya (fingolimod). Health Canada’s safety review established a potential link. The Canadian product monograph for Gilenya has been updated to inform about this potential safety issue. Health Canada has also communicated this information to healthcare professionals.

• Summary Safety Review – Gilenya (fingolimod)
• Health Product InfoWatch – Gilenya (fingolimod)

Opioid drugs

As part of the Government's action to reduce the harms of opioids, Health Canada held a Scientific Advisory Panel on Opioid Use and Contraindications to consider whether the current contraindications for opioid use are sufficient, or whether labelling updates and other actions may be needed to reduce risks to Canadians. After thoroughly assessing the Panel's recommendations, Health Canada is working with manufacturers to update the Canadian labelling of all prescription opioid products. Labelling updates include a recommendation for a daily opioid threshold dose for the management of chronic non-cancer, non-palliative pain; a recommendation to limit the quantity of opioids prescribed for acute pain; and clarification of warnings, including those for special populations such as pregnant women and patients with a history of dependence or substance use disorder.

• Information Update – Opioid drugs

Proton pump inhibitors (PPIs)

This safety review evaluated the risk of subacute cutaneous lupus erythematosus (SCLE) associated with proton pump inhibitors (PPIs). Health Canada’s safety review concluded that there is a rare risk of SCLE associated with PPI use. Canadian product monographs for all PPI-containing products will be updated to inform healthcare professionals and patients.

• Summary Safety Review – Proton pump inhibitors (PPIs)

Sedative and anesthetic drugs

This safety review evaluated the risk of neurodevelopmental disorders associated with sedative and anesthetic drugs: desflurane, isoflurane, ketamine, propofol and sevoflurane. Health Canada’s review concluded that repeated or lengthy use (more than 3 hours) of these sedative and anesthetic drugs in pregnancy and in children up to approximately 3 years of age may potentially lead to neurodevelopmental disorders in children. The Canadian product monographs of these drugs will be updated with warnings about this potential risk. Health Canada will also look into working with the Drug Safety and Effectiveness Network to further study the link between the use of sedative and anesthetic drugs and the development of the brain. Health Canada has also communicated this information to Canadians.

• Summary Safety Review – Sedative and anesthetic drugs
• Information Update – Sedative and anesthetic drugs

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 – Multiple unauthorized drugs seized in Richmond, B.C.
• Advisory – Smart Brain Formulations Serotonin Support
• Advisory – Ultra Pure Colloidal Silver
• Update – Products manufactured by Robert Lamberton Consulting, Cutting Edge Naturals and Cutting Edge Nutraceuticals
• Update – Sexual enhancement products

Zydelig (idelalisib)

This safety review evaluated the risk of progressive multifocal leukoencephalopathy (PML) associated with Zydelig (idelalisib). Health Canada’s review concluded that there was a possible link. The Canadian product monograph will be updated to include a warning about this risk.

• Summary Safety Review – Zydelig (idelalisib)