Health Product InfoWatch – February 2018

Contents

• Health products mentioned in this issue
• Monthly recap
• New information
  • Product monograph update: Alcaine (proparacaine hydrochloride)
  • Product monograph update: Concerta (methylphenidate hydrochloride)
  • Product monograph update: Zoloft (sertraline hydrochloride)
• Scope
  • Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

Pharmaceuticals and Biologics

Alcaine (proparacaine hydrochloride)
Alogliptin
Avonex (interferon beta-1a)
Concerta (methylphenidate hydrochloride)
Dianeal, PD4 1.5% 5L SYSII
Dipeptidylpeptidase-4 inhibitors
EpiPen (epinephrine)
HYDROmorphone hydrochloride injection USP
Linagliptin
Ofev (nintedanib)
Saxagliptin
Sitagliptin
Zoloft (sertraline hydrochloride)

Medical Devices

Barbed (knotless) sutures

Natural Health Products

Flintstones Plus Iron multivitamins for children

Other

Foreign health products
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 January 2018 by Health Canada.

Avonex (interferon beta-1a)

This safety review evaluated the risk of sarcoidosis associated with Avonex (interferon beta-1a). Health Canada's review of the available information did not find a link. Health Canada has asked the manufacturer of Avonex to actively monitor the risk of sarcoidosis in patients worldwide and to report these to Health Canada.

Summary Safety Review - Avonex (interferon beta-1a)

Barbed (knotless) sutures

This safety review evaluated the risk of small bowel obstruction associated with barbed (knotless) sutures. Health Canada's review of the available information has confirmed the potential for barbed sutures used in surgeries in the stomach area and below to hook onto the small intestine and result in a blockage. Health Canada will work with manufacturers to update the instructions for use for all barbed sutures to include details about this potential risk.

Summary Safety Review - Barbed (knotless) sutures

Dianeal, PD4 1.5% 5L SYSII

Baxter Corporation recalled one lot (lot number W7K16T1B) of Dianeal PD4 1.5% peritoneal dialysis solution in the 5-litre bag format due to the potential presence of particulate matter within the connectors.

Advisory - Dianeal, PD4 1.5% 5L SYSII
Drug Recall - Dianeal, PD4 1.5% 5L SYSII

Dipeptidylpeptidase-4 inhibitors

This safety review evaluated the risk of bullous pemphigoid associated with dipeptidylpeptidase-4 inhibitors (gliptins): alogliptin, linagliptin, saxagliptin and sitagliptin. Health Canada's safety review concluded that there may be a link. Health Canada has asked that manufacturers update the Canadian product monographs for all DPP-4 inhibitors to contain warnings for this risk.

Summary Safety Review - Dipeptidylpeptidase-4 inhibitors

EpiPen (epinephrine)

Pfizer Canada advised Health Canada that there is currently a shortage of EpiPen auto-injectors in the 0.3 mg format. The shortage is reported to be due to a manufacturing disruption and is anticipated to be resolved by March 2, 2018. The shortage does not impact EpiPen Jr (0.15 mg) products, which remain available.

Information Update - EpiPen (epinephrine)

Flintstones Plus Iron multivitamins for children

One bottle of children's Flintstones Plus Iron multivitamins was returned to a pharmacy containing unidentified capsules instead of the proper chewable tablets. The opened bottle with the safety seal removed was returned to a Pharmaprix in Longueuil, QC, in December 2017.

Advisory - Flintstones Plus Iron multivitamins for children

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

HYDROmorphone hydrochloride injection USP

HYDROmorphone hydrochloride injection USP lot number 67240DD was recalled by Pfizer Canada Inc. Product sterility may be compromised in the affected lot due to the possibility of cracked vials.

Drug Recall - HYDROmorphone hydrochloride injection

Ofev (nintedanib)

Cases of drug-induced liver injury (DILI), including one fatal outcome, have been reported in patients treated with Ofev (nintedanib). Healthcare professionals are advised to monitor patients' liver transaminases and bilirubin levels just before starting treatment, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Health Canada is working with the manufacturer to include this safety information in the Canadian Product Monograph.

Health Professional Risk Communication - Ofev (nintedanib)

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 - Kratom and sexual enhancement products
Update - Sexual enhancement products