Health Product InfoWatch – February 2019
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Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
Organization: Health Canada
- Health products mentioned in this issue
- Announcement – Update on Biologics Naming
- Monthly recap
- New information
- Reporting Adverse Reactions
- Helpful links
Health products mentioned in this issue
Pharmaceuticals and Biologics
- Fibristal (ulipristal acetate)
- Gilenya (fingolimod)
- Idhifa (enasidenib)
- Lartruvo (olaratumab)
- Spinraza (nusinersen)
Update on Biologics Naming
Health Canada has released a policy statement on the naming of biologic drugs. The naming convention for biologic drugs, including biosimilars, will consist of a unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Both brand name and non-proprietary name should be used throughout the medication use process. All biologic drugs will continue to have unique Drug Identification Numbers.
Health Canada thanks those who responded to the 2018 Consultation on the Naming of Biologic Drugs. A What We Heard Report summarizing the results of the consultation has also been published.
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 January 2019 by Health Canada.
Fibristal (ulipristal acetate)
Health Canada informed Canadians that its safety review of Fibristal (ulipristal acetate) found a possible link between its use and the risk of a rare but serious liver injury. Health Canada has worked with the manufacturer to update the Canadian product monograph for Fibristal to include new restrictions for use as well as requirements for liver function monitoring before, during and after treatment.
This safety review evaluated the risk of non-melanoma skin cancer (NMSC) associated with hydrochlorothiazide (HCTZ). Health Canada's review of the relevant evidence concluded that there is a potential risk of developing NMSC with prolonged use of HCTZ. However, uncertainty remains due to limitations noted in the reviewed studies. Patients taking HCTZ-containing products should be advised to regularly check their skin for new lesions as well as changes to existing lesions and report any suspicious skin lesions. Patients should be advised to practice routine sun-safety. Alternatives to HCTZ may be considered for patients who are at a particularly high risk for NMSC. Health Canada will work with the manufacturers to update the product monographs of all HCTZ-containing products. Health Canada also communicated this information to healthcare professionals and to the public.
- Health Product InfoWatch – Hydrochlorothiazide
- Information Update – Hydrochlorothiazide
- Summary Safety Review – Hydrochlorothiazide
The global, Phase III study (ANNOUNCE) of Lartruvo used in combination with doxorubicin did not confirm the clinical benefit in prolonging lives of patients with advanced or metastatic soft tissue sarcoma compared to doxorubicin alone. Based on the information available, no new safety concerns were identified during the study. Patients who currently are receiving Lartruvo should discuss with their physician whether to continue their course of therapy. Lartruvo should not be initiated in new patients outside of an investigational setting.
This safety review evaluated the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with sulfamethoxazole-containing products. Health Canada's review of the available information concluded that there is not enough evidence at this time to establish a link between the risk of DRESS and the use of sulfamethoxazole-containing products. Additionally, some of the signs and symptoms of DRESS are already included in the Canadian product monographs. For these reasons, Health Canada's review concluded that the safety information for these products is appropriate at this time.
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, 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.
The risk of multiple sclerosis rebound (return of disease activity) after fingolimod discontinuation has been included in the Warnings and Precautions section of the Canadian product monograph for Gilenya.
Key messages for healthcare professionals: Footnote 1
- In the post-marketing setting, severe exacerbation of disease activity has been observed rarely in some patients stopping fingolimod.
- Healthcare professionals are advised to monitor patients for development of high disease activity following discontinuation of Gilenya and begin appropriate treatment as needed.
- Footnote 1
Gilenya (fingolimod) [product monograph]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2018.
The risk of hydrocephalus has been included in the Warnings and Precautions and Patient Medication Information sections of the Canadian product monograph for Spinraza.
Key messages for healthcare professionals:Footnote 2
- There have been reports of communicating hydrocephalus not related to meningitis or bleeding in patients treated with Spinraza in the post-market setting. A ventriculo-peritoneal shunt (VPS) was implanted in some patients to treat this condition.
- At present, the benefits and risks of Spinraza treatment in patients with VPS are unknown. The maintenance of treatment needs to be carefully considered.
- Physicians are advised to closely monitor patients with decreased consciousness and consider an evaluation for hydrocephalus.
- Footnote 2
Spinraza (nusinersen) [product monograph]. Mississauga (ON): Biogen 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.
Idhifa (enasidenib): Authorization with conditions
Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy for Idhifa (enasidenib), 50 mg, 100 mg tablets for oral use. Idhifa is indicated for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. 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 Idhifa Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Celgene Inc. Web site or by contacting Celgene Inc. at 1-877-923-5436. 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
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.
- MedEffect™ 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
- Annual trends for adverse reaction case reports and medical device problem incidents
Your comments are important to us. Let us know what you think by reaching us at HC.infowatch-infovigilance.SC@canada.ca
Marketed Health Products Directorate
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Ottawa ON K1A 0K9
© 2019 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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