Health Product InfoWatch - April 2017
Pub. no 160256
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
- Monthly recap
- New information
- Product monograph update: Amiodarone (intravenous)
- Product monograph update: Primaquine (primaquine phosphate)
- Product monograph update: Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate extended-release)
- Product monograph update: Tecfidera (dimethyl fumarate)
- Product monograph update: Valproate products (valproic acid, divalproex sodium)
Health products mentioned in this issue
Pharmaceuticals and Biologics
- Amiodarone (intravenous)
- Buckley’s syrups
- Depakene (valproic acid)
- Epival (divalproex sodium)
- Fluorouracil Injection
- Keytruda (pembrolizumab)
- Primaquine (primaquine phosphate)
- Seroquel (quetiapine fumarate)
- Seroquel XR (quetiapine fumarate extended-release)
- Tecfidera (dimethyl fumarate)
- Valproate products (valproic acid, divalproex sodium)
- Zydelig (idelalisib)
Monthly recap of health product safety information
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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