Health Product InfoWatch: October 2023

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

Published: 2023-10-25
Pub.: 230000
Cat.: H167-1E-PDF
ISSN: 2368-8025

Health products mentioned in this issue
Monthly recap of health product safety information
New health product safety information
Scope
Reporting Adverse Reactions
Helpful links
Suggestions?

Health products mentioned in this issue

Monthly recap of health product safety information

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in September 2023 by Health Canada.

Allergenic Extract Non Pollens

Certain lots of Allergenic Extract Non Pollens (Pecan Nut) were recalled as the affected lots may result in a false negative for skin test (pecan nut allergy).

Atropine Sulfate Injection USP

One lot of Atropine Sulfate Injection USP was recalled as the affected lot may contain the presence of glass particulate.

Type 1 drug recall: Atropine Sulfate Injection USP

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.

New health product safety information

The following topics have been selected to raise awareness and encourage reporting of adverse reactions.

Safety briefs

Use of probiotics in preterm infants

In Canada, probiotic natural health products (NHPs) are authorized under the Natural Health Products Regulations. These products contain live microorganisms (single and/or multi-strain bacteria and/or yeast) and are indicated to help support intestinal/gastrointestinal health and to promote a favorable gut flora in authorized populations.^{Footnote 1} Probiotic NHPs are contraindicated in certain vulnerable populations, such as immunocompromised individuals, due to the risk of infection (e.g., bacteremia, fungemia and sepsis).^{Footnote 1,}^{Footnote 2,}^{Footnote 3}

Market Authorization Holders (MAHs) of probiotic NHPs must meet specific quality standards (as outlined in Health Canada's Probiotics monograph) at the time of authorization. These quality standards are expected to be maintained thereafter by the MAHs or the product manufacturers. These standards are related to strain identity, microbial impurities, chemical contaminants, antibiotic resistance, virulence factor production, and toxigenic activity.^{Footnote 1}^{Footnote 4} The quality standards put in place by Health Canada with respect to probiotic NHPs are specifically tailored for authorized indications and populations.

As of October 2023, Health Canada has received 5 serious (including 3 deaths) domestic adverse reaction reports involving preterm infants who were administered a probiotic NHP in hospitals for the prevention of necrotizing enterocolitis (NEC). This practice is considered off-label as probiotic NHPs are not authorized for use in preterm infants. Sepsis and bacteremia were reported in the 3 fatal cases. Upon evaluation by Health Canada, a causal association between probiotic exposure and the adverse events could not be established for the 5 reported cases.

While the off-label use of health products, including probiotic NHPs, falls within the scope of the practice of medicine, Health Canada is reminding healthcare professionals that there are currently no probiotic NHPs authorized by Health Canada for preterm infants nor for the prevention of NEC. The safety and efficacy of probiotics for this subpopulation and indication have not been substantiated through evidence submitted to and reviewed by Health Canada. The Department is providing this information to help healthcare professionals weigh the risks and benefits when deciding on appropriate treatments for their patients.

Healthcare professionals are encouraged to report to the Canada Vigilance Program any adverse reactions suspected of being associated with the use of probiotics including, but not limited to, adverse reactions associated with off-label use in preterm infants.

Health Canada will continue to monitor the safety of probiotics, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.

Omnipod Insulin Management Systems and the risks of Pod detachment and needle deformation

The Omnipod and Omnipod Dash Insulin Management Systems (Omnipod) are intended for subcutaneous delivery of insulin at set and variable rates to control blood glucose levels in people with diabetes mellitus who require insulin. They are licensed in Canada as Class III medical devices.

The Omnipod contains 2 parts:

a Pod, which is a single-use disposable device, filled with insulin and placed directly on the body for up to 72 hours (3 days) to deliver a maximum of 200 units of insulin; and
a Personal Diabetes Manager (PDM), which is a remote controller that manages insulin delivery from the Pod.

Since Health Canada's 2018 review of the Omnipod system, the Department has continued to monitor reports of adverse events associated with the system. Through this ongoing monitoring, Health Canada has investigated new complaints related to Pod detachment or deformation of the Pod's needle during insertion into the skin.

Health Canada's investigation found that these risks are often associated with Pod misuse, such as wearing the Pod for longer than recommended or inserting the Pod in a non-recommended infusion site. Although the device labelling provides detailed instructions on Pod placement, insertion, replacement and care, including warnings and precautions to help mitigate risks, this information may be overlooked by patients. A lack of understanding of the safe and proper use of the device may result in an interruption of insulin delivery to the patient, potentially leading to adverse events, which can include hyperglycemia, diabetic ketoacidosis or diabetic coma.

Recognizing the important role that healthcare providers have in onboarding patients to new diabetes management systems, Health Canada would like to highlight certain aspects of the manufacturer's labelling to facilitate patient counselling.

The manufacturer recommends that patients:

Select an appropriate placement site for the Pod on their body. Ideal sites for Pod placement are body areas that have a layer of fatty tissue and offer easy access and viewing, such as the abdomen, hip, back of the upper arm, upper thigh, or lower back. Patients should avoid areas where belts, waistbands, or tight clothing may rub against, disturb or dislodge the Pod.
Change the site of Pod placement each time a new Pod is applied. The new site should be at least 2.5 cm (one inch) away from the last site.
Follow the manufacturer's step-by-step instructions when applying and verifying the placement of the Pod.
Check often to make sure the Pod and soft cannula are securely attached and in place. A loose or dislodged cannula may interrupt insulin delivery.
Replace the Pod at least once every 48 to 72 hours (2 to 3 days) or after 200 units of insulin have been delivered, or more often if recommended by their healthcare provider.

Health Canada will continue to monitor the safety of the Omnipod system and will take appropriate action should new health risks be identified. Healthcare providers are encouraged to report to Health Canada any adverse events suspected of being associated with the Omnipod.

Product monograph updates

The following safety labelling updates, which were recently made to the Canadian product monographs, have been selected for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada's Product monograph brand safety updates page. Canadian product monographs can be accessed through Health Canada's Drug Product Database.

Fosamax (alendronate sodium) and Fosavance (alendronate sodium and cholecalciferol)

The Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions) and Patient Medication Information sections of the Canadian product monographs for Fosamax and Fosavance have been updated with information about the risk of low-energy fractures observed in bones other than the femur. While atypical femoral fractures were previously reported in the product monographs, there is emerging post-market data showing fractures with atypical presentation occurring in bones other than the femur.

Key messages for healthcare professionals:^{Footnote 5,}^{Footnote 6}

Low-energy fractures of the subtrochanteric and proximal femoral shaft and other bones have been reported in some long-term (time to onset in the majority of reports ranged from 18 months to 10 years) alendronate-treated patients.
Some were stress fractures (some of which were reported as insufficiency fractures) occurring in the absence of apparent trauma or induced by mild external force.

Levothyroxine sodium products

The Warnings and Precautions, Drug Interactions, and Patient Medication Information sections of the Canadian product monographs for levothyroxine sodium products^{Footnote *} have been or will be updated with the risk of biotin interfering with streptavidin-based thyroid function immunoassays.

Key messages for healthcare professionals:^{Footnote 7,}^{Footnote 8,}^{Footnote 9}

Serum biotin may interfere with thyroid function immunoassays that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results. The risk of interference increases with higher doses of biotin.
When possible, it is recommended that patients abstain from taking biotin supplements for at least 2 days prior to specimen collection.
When interpreting results of laboratory tests, possible biotin interference should be taken into consideration, especially if a lack of coherence with the clinical presentation is observed.

Vaccine safety summary

Health Canada and the Public Health Agency of Canada (PHAC) share the responsibility of monitoring the safety of vaccines in Canada.

Market authorization holders are required to report serious adverse events following immunization (AEFIs) to the Canada Vigilance Program in Health Canada. The Canada Vigilance Program also receives voluntary reports from healthcare professionals and consumers.

While hospitals must report serious adverse drug reactions that are documented within their facility, they do not have to report an adverse reaction to a vaccine if they have submitted an AEFI report on that case to their local public health unit. These reports are submitted by provincial and territorial public health authorities to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) in PHAC.

This vaccine safety summary includes reports of AEFIs received by the Canada Vigilance Program between January 1, 2022, and December 31, 2022. The summary excludes reports where a COVID-19 vaccine was the sole vaccine suspected to be linked to the AEFI. For information about adverse events that individuals have reported after receiving a COVID-19 vaccine in Canada, please visit the Reported side effects following COVID-19 vaccination in Canada webpage.

Summary for January 1, 2022 to December 31, 2022

Key messages:

From January 1, 2022 to December 31, 2022, the Canada Vigilance Program received 402 reports of adverse events following immunization (AEFI) for which vaccines were the suspected cause.
There were no significant changes in the characteristics (sex and age) of the population who experienced the reported AEFIs, nor in the types of vaccines most frequently reported compared to previous years.
No new safety signals (potential safety issues) were identified for non-COVID vaccines during this period.

In 2022, the Canada Vigilance Program received 402 reports of AEFI for which vaccines were the suspected cause. The majority of the reports were received from consumers through spontaneous reporting (Figure 1).

**Figure 1 : Total number of reports received by reporter type**

Reporter type	Percentage (%)	Number of reports (n)
Consumer/other non health professional	51	204
Other health professional	23	94
Pharmacist	12	47
Physician	14	57

Most of the reports involved adults over 18 years of age (189 out of 402: 47%) (Figure 2), which is similar to what has been observed since 2013 when Health Canada began publishing periodic reports of AEFIs submitted to the Canada Vigilance Program.
The distribution by sex for the 402 reports was 59% female, 25% male and 16% unknown. This trend is similar to what has been observed previously.

**Figure 2 : Total number of reports received by age group**

Age group	Number of non-serious reports	Number of serious reports
Infant (28 days to 23 months)	0	13
Child (2-11 years)	1	8
Adolescent (12-18 years)	0	2
Adult (19-64 years)	24	72
Elderly (65 years and above)	11	82
Unknown	5	184

Vaccine type	Number of non-serious reports	Number of serious reports
Herpes Zoster	HZ	20	219
Influenza	INF	13	80
Pneumococcal	PNEU	5	36
COVID-19	COVID	3	34
Meningococcal	MEN	0	12
Varicella	VAR	1	11
Human papillomavirus	HPV	1	9
Measles, mumps, rubella	MMR	0	10
Hepatitis B	HB	2	7
Diphtheria, tetanus, acellular pertussis, and inactivated poliomyelitis	DTaP-IPV	0	7
Hepatitis A	HA	0	4
Rotavirus	ROT	0	4
Typhoid	Typh	1	3
Diphtheria, tetanus, acellular pertussis	DTaP	0	3
Tetanus	T	0	3
Hepatitis A and Hepatitis B	HAHB	0	2
Tetanus, diphtheria (reduced), acellular pertussis	TdaP	1	1
Hepatitis (type of hepatitis vaccine was not reported)	Hep	0	2
Tetanus, diphtheria (reduced)	Td	0	2
Measles, mumps, rubella, varicella	MMRV	0	2
Tetanus, diphtheria (reduced), acellular pertussis and inactivated poliomyelitis	TdaP-IPV	0	1
Smallpox	Sma	0	1
Cholera and Enterotoxigenic Escherichia Coli Travellers' Diarrhea	Chol Ecol	0	1
Inactivated poliomyelitis	IPV	0	1
Yellow fever	YF	1	0

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Date modified:: 2023-10-26

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Health Product InfoWatch: October 2023

Contents

Health products mentioned in this issue

Pharmaceuticals and biologics

Medical devices

Natural and non-prescription health products

Other