Health Product InfoWatch – July 2017

Health products mentioned in this issue

Pharmaceuticals and Biologics

Other

Announcement

Consultation – New measures to inform Canadians of the risks of prescription opioids

As part of the Government of Canada's work to reduce problematic opioid use and its related harms, Health Canada is proposing regulations that would make a warning sticker and patient information handout mandatory with all prescription opioids at the time of sale. The sticker would be applied by the pharmacist to the prescription opioid container to warn patients about the potential risks associated with opioid use, including dependence, addiction and overdose. The handout would contain broader information on the safe use of opioids, and on the risks associated with these drugs. Through the proposed regulations, the Minister of Health would also be able to require that pharmaceutical companies develop and implement risk management plans for all opioids to identify, mitigate and monitor risks associated with opioid use.

To finalize these regulations, Health Canada is asking Canadians to provide their comments via the Canada Gazette Web site. These consultations will be open until August 31, 2017.

News Release

Announcement

Government of Canada enables new access to drugs in urgent public health situations

The Government of Canada has taken action to make more treatment options available for the opioid crisis and other emergency situations by implementing new regulations that allow the import of drugs that are urgently needed in Canada.

Health Canada has published an initial List of drugs for an urgent public health need that are authorized for sale in the United States, the European Union or Switzerland, but are not yet authorized in Canada. Health Canada will now permit these drugs to be imported into Canadian jurisdictions that have notified Health Canada of an urgent public health need.

Under these regulations, every healthcare institution authorized by the laws of a province to provide acute care services is required to report serious adverse drug reactions that involve a drug from the List to Health Canada.

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 June 2017 by Health Canada.

Brilinta (ticagrelor)

This safety review evaluated the risk of severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis, associated with Brilinta (ticagrelor). Health Canada's review concluded that there was not enough information available to confirm a link. Health Canada will continue to monitor this issue.

Summary Safety Review - Brilinta (ticagrelor)

Cefazolin for injection

Cefazolin Sodium 10 g/vial (lot number 303723) has been recalled by Fresenius Kabi Canada Ltd. as the affected lot may contain presence of foreign matter.

Drug Recall - Cefazolin for injection

Dipeptidylpeptidase-4 inhibitors

This safety review evaluated the risk of heart failure associated with dipeptidylpeptidase-4 (DPP-4) inhibitors. While Health Canada was carrying out the review, the manufacturers of DPP-4 inhibitors updated the Canadian product monographs to include information regarding the risk of heart failure. Health Canada's review of the available information concluded that the recently updated Canadian product monographs accurately describe the risk.

Summary Safety Review – Dipeptidylpeptidase-4 inhibitors

Finasteride

This safety review evaluated the risk of serious muscle-related adverse reactions associated with finasteride (Propecia, Proscar and generic products). Health Canada's review concluded that the risk of serious muscle-related adverse reactions with the use of finasteride could not be ruled out. Health Canada has recommended that the manufacturers update the Canadian product monographs of finasteride-containing products to inform about this risk.

Summary Safety Review – Finasteride

Foreign health products

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients. These 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

Mefloquine

This safety review evaluated the risk of rare long-lasting and permanent neurological and psychiatric adverse events associated with mefloquine. Health Canada's review concluded that there was limited evidence supporting this association. The review also found that some individuals were prescribed mefloquine even though they had contraindications against its use. Health Canada will be working with the manufacturer to update the Patient Medication Information section of the Canadian product monograph to better explain the type of neurological adverse events that may, very rarely, become permanent. A checklist will also be developed to assist healthcare professionals in deciding whether to prescribe mefloquine to individual patients.

Narcan (naloxone) nasal spray

Health Canada advised healthcare professionals and Canadians that the Canadian authorized version of Narcan (naloxone) nasal spray has transitioned onto the market. Last July, an Interim Order was issued by the Minister of Health, permitting the importation, sale and distribution of Narcan approved in the United States for a period of one year. Health Canada has now authorized the Canadian version of Narcan. Narcan is the same product in Canada and the United States with minor labelling differences being the only distinctions.

Information Update - Narcan (naloxone)

Sodium bicarbonate injection

Health Canada informed Canadians of the current shortage of injectable sodium bicarbonate product in Canada. The global supply of the vials has been tight since late May due to manufacturing delays. In addition, Pfizer Canada recalled 2 lots (lot numbers 72119EV and 72120EV) of 8.4% sodium bicarbonate injection, USP, 50 mL vials, due to possible microbial contamination in the manufacturing process. The recall did not affect the pre-filled syringe format.

Tecfidera (dimethyl fumarate)

This safety review evaluated the risk of kidney injury associated with Tecfidera (dimethyl fumarate). Health Canada's review concluded that there is limited evidence at this time suggesting kidney injury with Tecfidera. The findings of this review are already reflected in the Canadian product monograph. Health Canada has asked the manufacturer to provide additional safety information on this risk as it becomes available.

Summary Safety Review - Tecfidera (dimethyl fumarate)

Tysabri (natalizumab)

This safety review evaluated the risk of hematological abnormalities in newborns whose mothers were treated with Tysabri (natalizumab) during pregnancy. Health Canada's review concluded that there is a potential for hematological abnormalities to happen in these newborns. The Canadian product monograph has been updated to reflect this risk.

Summary Safety Review - Tysabri (natalizumab)

Unauthorized health products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online.

Volulyte and Voluven (hydroxyethyl starch)

This safety review evaluated the risk of acute kidney injury in non-critically ill patients associated with hydroxyethyl starch (Voluven and Volulyte). Health Canada's review concluded that there was not enough information to establish a link. Health Canada has requested additional safety information from the manufacturer as it becomes available.

Summary Safety Review - Voluven and Volulyte (hydroxyethyl starch)

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