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Drugs and Health Products

Health Product InfoWatch - April 2017

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ISSN 2368-8025
Pub. no 160256

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team

Scope, reporting and contact information, helpful links

Contents

Health products mentioned in this issue

Pharmaceuticals and Biologics

Medical Devices

Other

Monthly recap of health product safety information

The following is a list of health product advisories as well as summaries of completed safety reviews published in March 2017 by Health Canada.

Buckley’s syrups

Health Canada advised Canadians that GlaxoSmithKline Consumer Healthcare Inc. recalled certain Buckley’s syrup products from stores. A defect with the plastic seal may cause it to fall into the bottle and present a potential choking hazard if swallowed.

Advisory – Buckley’s syrups

Esophageal stents

This safety review evaluated and confirmed the risk of esophageal and vascular erosion associated with esophageal stents. Health Canada will work with device manufacturers to update the safety information for all esophageal stents to include details about this potential risk and factors that may increase this risk. Health Canada has also communicated this information to healthcare professionals.

Summary Safety Review - Esophageal stents
Health Product InfoWatch - Esophageal stents

Fluorouracil Injection, BP (5-fluorouracil) 5 g/100 mL

As an update to the October 2016 risk communication, and in light of the reported shortage for this drug, Health Canada facilitated the release of Fluorouracil vials. The vials had previously been quarantined by the company due to the risk associated with the possibility of cracks or leaks. Vials that show cracks, leakage, or white powder on the outside of the vial should not be used.

Health Product Risk Communication (update) – Fluorouracil Injection

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 (14 products)
Foreign Product Alert (16 products)

Keytruda (pembrolizumab)

Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some with fatal outcomes, have been reported in patients treated with Keytruda. Healthcare professionals are advised to counsel patients about the benefits and risks of Keytruda; suspend Keytruda treatment and refer for immediate specialized evaluation and treatment if a patient reports any severe skin reaction, or in a case of suspected SJS or TEN; and permanently discontinue Keytruda if SJS or TEN is confirmed. Health Canada is currently working with the manufacturer to include this safety information in the Canadian product monograph.

Health Product Risk Communication - Keytruda (pembrolizumab)

Unauthorized health product (PureCare Herbal Cream)

Health Canada advised Canadians that the unauthorized health product “PureCare Herbal Cream” may pose serious health risks. The product is promoted as a natural treatment for eczema and psoriasis in children and babies. Health Canada testing confirmed the presence of clobetasol propionate and phenoxylethanol not declared on the product label.

Advisory – Unauthorized health product (PureCare Herbal Cream)

Unauthorized health products (Botulax and The Lift II)

Health Canada advised Canadians that it seized the unauthorized injectable health product “Botulax” and unauthorized medical sutures “The Lift II” from SPMU-MTS Studio in Richmond, BC. Botulax is labelled to contain botulinum toxin type A and was being administered as an injectable treatment for cosmetic purposes. The Lift II is an absorbable suture used to close incisions after surgery. Neither product is authorized for sale in Canada.

Advisory - Unauthorized health products (Botulax and The Lift II)

Unauthorized health products (EPCA Shipping Inc.)

Health Canada advised Canadians that it seized several unauthorized health products from EPCA Shipping Inc. in Richmond, BC. The products are promoted to treat cancer, infertility, respiratory diseases, enlarged thyroid and erectile dysfunction, and are labelled to contain various prescription drugs.

Advisory – Unauthorized health products (EPCA Shipping Inc.)

Unauthorized health products promoted for sexual enhancement

Health Canada advised Canadians that it seized multiple unauthorized health products from 3 retailers in Ontario. The products are promoted for sexual enhancement and were found to contain, or are labelled to contain, prescription drugs (dapoxetine, sildenafil, tadalafil and yohimbe).

Advisory – Unauthorized health products for sexual enhancement

Zydelig (idelalisib)

This safety review evaluated the risk of serious infections associated with Zydelig (idelalisib). Health Canada’s review concluded that there was a risk of serious infections, which may lead to death, associated with Zydelig use. The Canadian product monograph has been updated to warn about the increased risk of infections. Health Canada has requested the manufacturer to provide any new information on this safety issue.

Summary Safety Review- Zydelig (idelalisib)

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