Health Product InfoWatch - August 2018
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
Organization: Health Canada
- Health products mentioned in this issue
- Monthly recap
- New information
- Helpful links
Health products mentioned in this issue
- Pharmaceuticals and Biologics
- Alunbrig (brigatinib)
- Avalide (irbesartan and hydrochlorothiazide)
- Avapro (irbesartan)
- EpiPen and EpiPen Jr (epinephrine)
- Imbruvica (ibrutinib)
- Remicade (infliximab)
- SGLT2 inhibitors
- Tactupump and Tactupump Forte (adapalene and benzoyl peroxide)
- Tromboject (sodium tetradecyl sulfate)
- Valsartan-containing drugs
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 July 2018 by Health Canada.
EpiPen and EpiPen Jr (epinephrine)
Following Health Canada's most recent communication regarding a shortage of EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injectors, Pfizer Canada has advised Health Canada that supply of EpiPen in the 0.3 mg format is expected to be very limited at pharmacies during the month of August. The company has also advised that, at this time, they continue to be able to supply EpiPen Jr (0.15 mg); however, the supply is limited and is being carefully managed at the national level.
Information Update - EpiPen and EpiPen Jr (epinephrine)
This safety review evaluated the risk of ventricular tachyarrhythmia associated with the use of Imbruvica (ibrutinib). Health Canada's review of the available information concluded that there may be a link. The Canadian product monograph for Imbruvica has been updated to include this risk. Health Canada also communicated this information to healthcare professionals.
This safety review evaluated the risk of linear IgA bullous dermatosis associated with the use of Remicade (infliximab). Health Canada's review of the available information concluded that there may be a link. The Canadian product monograph for Remicade has been updated to include this risk.
Summary Safety Review - Remicade (infliximab)
This safety review evaluated the risk of acute and chronic pancreatitis associated with sodium-glucose cotransporter-2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, and empagliflozin). Health Canada's review of the available information concluded that there may be a link between the use of SGLT2 inhibitors and acute pancreatitis. However there was limited evidence to suggest a link with chronic pancreatitis. Health Canada is working with the manufacturers to update the Canadian product monographs for SGLT2 inhibitors to include this risk.
Summary Safety Review - SGLT2 inhibitors
Tromboject (sodium tetradecyl sulfate)
Vials of Tromboject 1% and 3% may contain visible and insoluble particles. Healthcare professionals are advised to use the product only when the benefits of Tromboject 1% and 3% therapy outweigh the risk of the treatment for medically necessary interventions or in conditions where there are no therapeutic alternatives for the patient. The product should be conserved only for medically necessary use due to the anticipated drug shortage of all Tromboject formats.
Health Professional Risk Communication - Tromboject (sodium tetradecyl sulfate)
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.
Advisory - Unauthorized health products
Several drugs containing valsartan were recalled by their manufacturers (a list of affected products with DIN and lot number is provided in the advisory and information update). An impurity, N-nitrosodimethylamine (NDMA), a potential human carcinogen, was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals.
- Advisory - Valsartan-containing drugs
- Information Update - Valsartan-containing drugs
- Drug recall - Pro Doc Valsartan
- Drug recall - Sandoz Valsartan
- Drug recall - Sanis Valsartan
- Drug recall - Sivem Valsartan
- Drug recall - Teva Valsartan
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.
Avapro (irbesartan) and Avalide (irbesartan and hydrochlorothiazide)
The risk of psoriasis exacerbation has been included in the Warnings and Precautions, Post-Market Adverse Reactions, and Consumer Information sections of the Canadian product monographs for Avapro and Avalide.
Key messages for healthcare professionals:Footnote 1,Note de bas de page 2
- The use of Avapro and Avalide in patients with psoriasis or a history of psoriasis should be carefully weighed as it may exacerbate psoriasis.
- Footnote 1
Avalide (irbersartan and hydrochlorothiazide) [product monograph]. Laval (QC): sanofi-aventis Canada Inc.; 2018.
- Footnote 2
Avapro (irbesartan) [product monograph]. Laval (QC): sanofi-aventis Canada Inc.; 2018.
Tactupump and Tactupump Forte (adapalene and benzoyl peroxide)
The use of Tactupump and Tactupump Forte is now contraindicated in pregnant women and in women planning a pregnancy. This information has been included in the Contraindications and Warnings and Precautions sections of the Canadian product monograph for Tactupump and Tactupump Forte.
Key messages for healthcare professionals:Footnote 3
- Orally administered retinoids, including adapalene, have been associated with congenital abnormalities.
- Topical adapalene/benzoyl peroxide is contraindicated in pregnant women and in women planning a pregnancy because of the possibility of increased systemic exposure due to various factors, such as damaged skin barrier and excessive use.
- If the patient becomes pregnant while using these drugs, treatment should be discontinued.
- Footnote 3
Tactupump and Tactupump Forte (adapalene and benzoyl peroxide) [product monograph]. Thornhill (ON): Galderma Canada Inc.; 2018.
Notice of market authorization with conditions
A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the nature of authorization granted.
Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.
The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada, in accordance with the NOC/c Policy. For the most up-to-date information, consult Health Canada's NOC database.
Alunbrig (brigatinib): Authorization with conditions
Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy for Alunbrig (brigatinib) 30 mg, 90 mg and 180 mg tablets. Alunbrig is indicated as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer who have progressed on or who were intolerant to an ALK inhibitor (crizotinib). Patients should be advised about the conditional market authorization for this indication.
For the complete prescribing information and information available for the patients/caregivers, please consult the Alunbrig Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Takeda Canada Website or by contacting Takeda Canada Inc. at 1-866-295-4636. Contact the company for a copy of any references, attachments or enclosures.
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.
- MedEffectTM Canada
- Recalls and Safety Alerts Database
- New Safety Reviews
- Canada Vigilance Adverse Reaction Online Database
- Drug Product Database
- Medical Devices Active Licence Listing
- Licensed Natural Health Products Database
- The Drug and Health Product Register
- Drug Shortages Canada
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
©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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