Health Product InfoWatch – February 2019

Contents

• Health products mentioned in this issue
• Announcement – Update on Biologics Naming
• Monthly recap
• New information
  • Product monograph update:  Gilenya (fingolimod)
  • Product monograph update:  Spinraza (nusinersen)
  • Notice of market authorization with conditions: Idhifa (enasidenib)
• Scope
• Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

Pharmaceuticals and Biologics

• Fibristal (ulipristal acetate)
• Gilenya (fingolimod)
• Hydrochlorothiazide
• Idhifa (enasidenib)
• Lartruvo (olaratumab)
• Spinraza (nusinersen)
• Sulfamethoxazole

Other

• Unauthorized health products

Announcement

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.

• Information Update – Fibristal (ulipristal acetate)

Hydrochlorothiazide

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

Lartruvo (olaratumab)

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.

• Health Professional Risk Communication – Lartruvo (olaratumab)

Sulfamethoxazole-containing products

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.

• Summary Safety Review – Sulfamethoxazole-containing products

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 – Panasilver
• Advisory – Products sold by A1 Herbal Ayurvedic Clinic Ltd.

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)

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.

Reference

Spinraza (nusinersen)

The risk of hydrocephalus has been included in the Warnings and Precautions and Patient Medication Information sections of the Canadian product monograph for Spinraza.

Reference

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.

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

• 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

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

© 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.