May 2024 Edition of Health Product InfoWatch
Contents
Monthly Summary of Health Product Safety Information
This article presents a compilation of health product advisories, type I drug recalls, and summaries of completed safety evaluations released in April 2024 by Health Canada.
Cisatracurium Omega (Cisatracurium Besylate Injection 2 mg/mL)
Due to a supply shortage of Cisatracurium Omega (Cisatracurium Besylate Injection 2 mg/mL) in Canada and its critical medical application, Health Canada has sanctioned the exceptional, temporary importation and distribution of Cisatracurio Hikma 2 mg/mL, which is authorized in Italy and labeled exclusively in Italian. Healthcare practitioners should be informed of the key differences between the Italian-authorized Cisatracurio Hikma 2 mg/mL and the Canadian Cisatracurium Omega products. For proper usage details, refer to the Canadian product monograph for Cisatracurium Omega Single Dose from Omega Laboratories Limited.
Health Product Risk Communication: Cisatracurium Omega (Cisatracurium Besylate Injection 2 mg/mL)
JAMP Guanfacine XR
JAMP Pharma Corporation has recalled one lot of JAMP Guanfacine extended release (XR) 4 mg tablets due to potential contamination with foreign substances during the production process. This foreign matter, comprised of cellulose, lubricant oil, calcium, and/or iron oxide, results in discoloration, causing the tablets to appear brown or amber. While these contaminants are not anticipated to pose severe health threats, it is advisable to replace any stained medication.
Neulasta (pegfilgrastim)
This safety evaluation assessed the possible risks of Stevens-Johnson syndrome and toxic epidermal necrolysis linked to Neulasta usage. Health Canada’s investigation found insufficient evidence to substantiate such a connection. Continuous monitoring of Neulasta’s safety will be conducted moving forward.
Summary Safety Review: Neulasta (pegfilgrastim)
PMS-Duloxetine
Recalls have been issued for specific lots of PMS-Duloxetine 30 mg and 60 mg capsules due to exceeding the interim allowable intake threshold for N-nitroso-duloxetine (NDLX).
Type 1 drug recall: PMS-Duloxetine 30 mg
Type 1 drug recall: PMS-Duloxetine 60 mg
Unauthorized Health Products
Health Canada has issued advisories pertaining to various unauthorized health products that are being sold in stores or online throughout Canada, which may pose significant health risks.
Advisory: Fake Viagra seized from Jug City store in Scarborough, ON
Advisory: Unauthorized health products seized from Vanette Keast Health Consulting in Red Deer, Alberta
Advisory: Unauthorized sexual enhancement products
Recent Health Product Safety Updates
The topics listed below have been selected to enhance awareness and prompt reporting of adverse effects.
Product Monograph Updates
Losec (omeprazole) and Losec Mups (omeprazole magnesium)
The sections on Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions), and Patient Medication Information in the Canadian product monographs for Losec and Losec Mups have been revised to include the risk of acute tubulointerstitial nephritis.
Key messages for healthcare professionals:Footnote 1 Footnote 2
- There have been instances of acute tubulointerstitial nephritis (TIN) in individuals using omeprazole, which can arise at any time during treatment.
- Acute TIN has the potential to lead to renal failure.
- In the event of suspected TIN, it is essential to discontinue omeprazole and initiate appropriate treatment without delay.
- Patients should be encouraged to consult their healthcare provider if they experience signs indicative of kidney inflammation (reduced urine output, blood in urine, fever, rash, joint stiffness).
Health Canada, together with manufacturers, will strive to incorporate similar information regarding the risk of acute TIN into the Canadian product monographs for all authorized proton pump inhibitors across Canada.
Vyvanse (lisdexamfetamine dimesylate)
The Warnings and Precautions and Adverse Reactions (Post-Market Adverse Reactions) sections of the Canadian product monograph for Vyvanse have been updated to highlight the risk of QTc prolongation.
Key messages for healthcare professionals:Footnote 3
- Lisdexamfetamine dimesylate has been found to prolong the QTc interval in certain patients.
- Vyvanse must be used cautiously in those with an extended QTc interval, those taking drugs that affect the QTc interval, or those with relevant existing heart conditions or electrolyte imbalances.
- It should be noted that Vyvanse is contraindicated in individuals with symptomatic cardiovascular problems as well as in those with moderate to severe hypertension.
Scope
This publication is designed primarily for healthcare professionals and comprises details about pharmaceuticals, biologics, medical devices, and natural health products. It summarizes crucial health product safety information released in the previous month by Health Canada, in addition to a selection of new updates aimed at increasing awareness. The new information in this issue is selective, emphasizing clinically pertinent subjects that merit broader dissemination.
Reporting Adverse Reactions
Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada
For further details on reporting an adverse reaction, kindly visit the Adverse Reaction and Medical Device Problem Reporting page.
Helpful Links
Contact Us
Your feedback is valuable to us. Please share your thoughts by reaching out via:
infowatch-infovigilance@hc-sc.gc.ca
Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9
References
- Footnote 1
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Losec (omeprazole delayed release capsules) [product monograph]. Greifswald (Germany): Cheplapharm Arzneimittel GmbH, 2023.
- Footnote 2
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Losec Mups (omeprazole magnesium delayed release tablets) [product monograph]. Greifswald (Germany): Cheplapharm Arzneimittel GmbH, 2023.
- Footnote 3
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Vyvanse (lisdexamfetamine dimesylate) [product monograph]. Toronto (ON): Takeda Canada Inc., 2024.