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Health Product InfoWatch – December 2018

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

ISSN: 2368-8025

Cat.: H167-1E-PDF

Pub.: 180663

Organization: Health Canada

Published: 2018-12-##

Contents

Health products mentioned in this issue

Pharmaceuticals and Biologics

Natural Health Products

Other

Announcements:

Annual trends for adverse reaction case reports and medical device incident reports (2008-2017)

The Canada Vigilance Program is Health Canada's post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada.

The primary monitoring mechanisms include:

  • The Canada Vigilance (CV) System for the reporting of adverse drug reactions
  • The Canada Vigilance - Medical Device Problem Reporting system (CV-MDS) for the reporting of medical device incidents
  • The Canadian Medical Devices Sentinel Network (CMDSNet) program for the monitoring of medical device incidents in participating hospitals

Manufacturers and importers of prescription health products and medical devices are mandated by regulation to submit adverse event and medical device incident (MDI) reports to Health Canada. Health Canada also receives reports of adverse events and MDIs, submitted voluntarily, from consumers and healthcare professionals, and in the case of medical device incidents by hospitals participating in the CMDSNet program.

Health Canada recently posted a report providing a descriptive analysis of the types of adverse reactions, including case reports of health products and medical device incidents that have been submitted to Health Canada between 2008 and 2017.

Reported ADRs and MDIs form an important component of Canada's health product vigilance regime. Healthcare professionals are encouraged to report any adverse reactions suspected of being associated with the use of a health product to the Canada Vigilance Program. Medical Device Reports can be submitted via the Health Product Complaint Form. Reporting helps identify potential health risks to Canadians and adds important value to post-market surveillance activities.

Did you know?

The Canadian Medical Devices Sentinel Network (CMDSNet) is an active surveillance program that relies on a group of dedicated and trained representatives from acute or community-based healthcare facilities within Canada to provide high quality data reports about incidents associated with all types of medical devices. Only participating institutions can report via this program, and there is no cost to the organization other than their time to submit the reports to Health Canada. These detailed reports obtained from reporting institutions help to better characterize how organizations use certain devices, how problems are perceived and reported, and what may have contributed to a particular event.

The number of reporting healthcare organizations has risen from the original 10 in the pilot to 16 in 2017, with new participants joining each year. These health organizations represent over 260 hospitals and facilities across Canada. Organizations vary in size from one hospital to a whole provincial health authority that represents over 100 sites and 9,000 inpatient beds. CMDSNet is striving to achieve pan-Canadian representation in the Network, with ongoing recruitment efforts in Nunavut and Yukon. Health Canada also aims to recruit additional non-hospital sites, such as private clinics and long term care facilities.

Talc and the risk to human health 

Health Canada and Environment and Climate Change Canada have completed a joint draft screening assessment of talc.

The proposed conclusion is that breathing in loose talc powder may cause lung effects, such as coughing, trouble breathing, decreased lung function and fibrosis. The draft assessment also identified talc as a possible cause of ovarian cancer from exposure to the perineal area from the use of certain products containing talc. This draft assessment focuses on the safety of talc in self-care products such as cosmetics, natural health products and non-prescription drugs (e.g., baby, body, face and foot powders, diaper and rash creams, genital antiperspirants and deodorants, body wipes and bath bombs). The draft screening assessment did not identify human health risks from inhalation exposures from pressed talc powder products, oral talc exposures (e.g., oral exposure from tablet preparations) or other dermal exposures (non-perineal).

For more information please see the health professional risk communication. 

Healthcare professionals are invited to comment on the draft screening assessment, during the Canada Gazette, 60-day public comment period ending on February 6, 2019.

Opioid Updates

Now online - Did you know responses to Health Canada's call on the pharmaceutical industry to suspend marketing and advertising of opioids on a voluntary basis are available online?

In June 2018, the Minister of Health requested that manufacturers and distributors of opioids in Canada respond to the opioid crisis by immediately suspending any and all marketing and advertising of opioids to healthcare professionals, on a voluntary basis.

As part of its commitment to openness and transparency, Health Canada has made the Minister's letters and the responses received from industry available to the public. For more information and to access the responses received to date, please visit Health Canada's Response to the Call on the Pharmaceutical Industry to Voluntarily Suspend Marketing and Advertising of Opioids Web page.

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 November 2018 by Health Canada.

Acetaminophen syrups

All lots of children's strawberry-flavoured acetaminophen syrups labeled as Biomedic, Option+, or Laboratoires Trianon Inc. were recalled because of defective child-resistant safety caps.

Foreign health products

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s). 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.

Human placenta products

Health Canada is aware of individuals and companies that are offering processing services for the preparation of human placenta for consumption. To date, Health Canada has not authorized any health products containing human placenta for consumption in Canada. While consuming placenta is a personal choice, mothers and others who may be consuming placenta preparations should be aware of the potential risks associated with the practice for themselves and their babies. Human placenta is a biologic material and can contain infectious agents such as bacteria (e.g., Group B Streptococcus) and viruses (e.g., hepatitis or HIV).

Mylan-Valsartan

Four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) were recalled after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA). This latest recall is further to recent recalls and other actions taken in Canada and internationally as a result of NDEA and another impurity, N-nitrosodimethylamine (NDMA), being found in certain drugs.

Option+ and Personelle sunscreens

One lot each of Option+ Family Sunscreen Lotion SPF 50+ and Personnelle Sport Sunscreen Lotion SPF 50+ were recalled because of bacterial contamination. The sunscreens were found to contain multiple types of bacteria: Lactobacillus brevis and either Micrococcus luteus or Staphylococcus hominis novobiosepticus.

Store-brand pain or sinus relief tablets

Vita Health Products recalled several store-brand (Care+, Exact, Life and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Sunscreen products

This safety review evaluated the risk of skin reactions associated with sunscreen products (chemical action sunscreens). Health Canada's review concluded that there are no new safety concerns with sunscreen products, but that rare, mild to moderate skin reactions may develop in individuals who have an allergy or sensitivity to one or more ingredients in sunscreen products. The benefits of the regular use of sunscreen to prevent sunburn and reduce the risk of skin cancer continue to greatly outweigh any risk of local skin reactions. Health Canada also communicated this information to the public.

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.

Vita-X Revitalizing Capsules

Two versions of “Vita-X Revitalizing Capsules” by Lanlay Healthmetic Inc. may pose serious health risks. One version has a Natural Product Number (NPN) 80053009, indicating Health Canada authorization. The second version has no NPN and is not authorized by Health Canada. Health Canada tested the unauthorized version and found it to contain sildenafil, which was not declared on the label. Neither version of the product is authorized to contain sildenafil. As a result, Health Canada has suspended the product licence (NPN).

Xofigo (radium Ra 223 dichloride)

An increased incidence of fractures and trend for increased deaths has been reported in a clinical trial among patients receiving Xofigo in combination with abiraterone acetate and prednisone/prednisolone. Healthcare professionals are reminded that Xofigo is authorized in Canada for the treatment of patients with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease, and that Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone. The Canadian product monograph has been updated to include this new safety information.

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Product monograph updates

The following safety labelling updates, which were recently made to the Canadian product monograph, have been selected for your awareness. A complete list of safety labelling updates 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.

Gilenya (fingolimod)

To minimise the risk of severe adverse events in patients with cardiac conditions the Canadian product monograph for Gilenya has been revised. The use of Gilenya is now contraindicated in patients with pre-existing cardiac conditions indicated below. This information, which was previously in the Warnings and Precautions section, has been included in the Contraindications and Consumer Information sections of the Canadian product monograph forGilenya.

Key messages for healthcare professionals:Footnote 1

Gilenya is contraindicated in:

  • Patients who in the last 6 months had myocardial infarction, unstable angina pectoris, stroke/transient ischemic attack, decompensated heart failure (requiring inpatient treatment), or New York Heart Association Class III/IV heart failure.
  • Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs.
  • Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or sick-sinus syndrome, if they do not have a pacemaker.
  • Patients with a baseline QTc interval ≥500 msec.

Reference

Footnote 1

Gilenya (fingolimod) [product monograph]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2018.

Return to footnote 1 referrer

Imuran (azathioprine)  

The risk of macrophage activation syndrome has been included in the Serious Warnings and Precautions Box of the Canadian product monograph for Imuran. The Warnings and Precautions and Consumer Information sections have also been updated in relation to this issue.

Key messages for healthcare professionals:Footnote 2

  • There is potential increased susceptibility for developing macrophage activation syndrome (MAS) with the use of azathioprine. MAS is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease.
  • Physicians should be attentive to symptoms of infection such as Epstein-Barr virus and cytomegalovirus, as these are known triggers for MAS.
  • If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with azathioprine should be discontinued.

Reference

Footnote 2

Imuran (azathioprine) [product monograph]. Toronto (ON): Aspen Pharmacare Canada Inc.; 2018.

Return to footnote 2 referrer

Prezcobix (darunavir and cobicistat) and Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide)

The risk of substantially lower exposures of darunavir and cobicistat during pregnancy has been included in the Warnings and Precautions, Dosage and Administration (Recommended Dose and Dosage Adjustment), Action and Clinical Pharmacology (Special Populations and Conditions, Pregnancy) and Consumer Information sections of the Canadian product monographs for Prezcobix and Symtuza.

Key messages for healthcare professionals:Footnote 3Footnote 4

  • Prezcobix and Symtuza are not recommended for use during pregnancy. In a clinical trial of 7 pregnant women, darunavir and cobicistat in combination with a background regimen were evaluated in pregnant women during the second and third trimesters and postpartum (6-12 weeks). The pharmacokinetic data demonstrate that exposure to darunavir boosted with cobicistat was substantially lower during pregnancy compared with postpartum. There is no clinical data on the virologic response when Prezcobix or Symtuza is initiated during pregnancy.
  • These products should not be initiated in pregnant women. An alternative regimen is recommended for women who become pregnant during therapy with Prezcobix and Symtuza.

References

Footnote 3

Prezcobix (darunavir and cobicistat) [product monograph]. Toronto (ON): Janssen Inc.; 2018.

Return to footnote 3 referrer

Footnote 4

Symtuza (darunavir,cobicistat, emtricitabine,and tenofovir alafenamide) [product monograph]. Toronto (ON): Janssen Inc.; 2018.

Return to footnote 4 referrer

Vimpat (lacosamide)

The risk of ventricular tachyarrhythmia has been added to the Warnings and Precautions, Post-Market Adverse Reactions, Drug Interactions and Consumer Information sections of the Canadian product monograph for Vimpat.

Key messages for healthcare professionals:Footnote 5

  • In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been rarely reported. In rare cases, these events have led to asystole, cardiac arrest and death.
  • In patients who develop serious cardiac arrhythmia, Vimpat should be discontinued and a thorough clinical benefit/risk assessment should be performed before possibly restarting therapy.
  • Vimpat should be used with caution in patients:
    • with underlying proarrhythmic conditions such as patients with known cardiac conduction problems (e.g., marked first-degree atrioventricular block or sick sinus syndrome without pacemaker) or severe cardiac disease (e.g., myocardial ischemia/infarction, heart failure, structural heart disease, or cardiac sodium channelopathies).
    • treated with medicinal products affecting cardiac conduction, including antiarrhythmic drugs, sodium channel blocking antiepileptic drugs, pregabalin and beta-blockers.

Reference

Footnote 5

Vimpat (lacosamide) [product monograph]. Oakville (ON): UCB Canada Inc; 2018.

Return to footnote 5 referrer

Scope

This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

Reporting Adverse Reactions

Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada

For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.

Helpful links

Suggestions?

Your comments are important to us. Let us know what you think by reaching us at HC.infowatch-infovigilance.SC@canada.ca

Health Canada
Marketed Health Products Directorate
Address Locator 1906C
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Fax: 613-952-7738

Copyright

© 2018 Her Majesty the Queen in Right of Canada. This publication may be reproduced without permission provided the source is fully acknowledged. The use of this publication for advertising purposes is prohibited. Health Canada does not assume liability for the accuracy or authenticity of the information submitted in case reports.

Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.

Due to time constraints relating to the production of this publication, information published may not reflect the most current information.

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