Health Product InfoWatch – October 2017

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ISSN 2368-8025
Pub. no 160256

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

Scope, reporting and contact information, helpful links

Contents

Health products mentioned in this issue

Pharmaceuticals and Biologics

Medical Devices

Other

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 September 2017 by Health Canada.

Apo-Nitroglycerin sublingual spray

Apotex Inc. recalled one lot (lot 6G07) of its Apo-Nitroglycerin sublingual spray (0.4 mg/metered dose) as the spray pump may malfunction and not deliver the drug.

Advisory - Apo-Nitroglycerin

Atypical antipsychotics

This safety review evaluated the risk of sleep walking and sleep-related eating disorder (SRED) associated with atypical antipsychotics (aripiprazole, asenapine, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone). Health Canada's safety review has found a link between sleep walking and SRED and the use of atypical antipsychotics. Health Canada has recommended to update the Canadian product monographs for all atypical antipsychotics to include these adverse reactions.

Summary Safety Review - Atypical antipsychotics

Invokana (canagliflozin) and Invokamet (canagliflozin and metformin)

An approximately two-fold increased risk of surgical lower limb amputation has been observed in two long-term clinical studies in type 2 diabetes patients with established cardiovascular disease (CVD) or at least two risk factors for CVD treated with Invokana. Healthcare providers are reminded to follow established diabetes care practice guidelines in patients treated with canagliflozin. The Canadian product monographs of Invokana and Invokamet will be updated to reflect this safety information.

Health Professional Risk Communication - Invokana (canagliflozin) and Invokamet (canagliflozin and metformin)

Levonorgestrel-releasing intrauterine systems

This safety review evaluated the risk of suppressed lactation associated with levonorgestrel-releasing intrauterine systems (Mirena, Jaydess and Kyleena). Health Canada's review concluded that there is currently limited evidence to suggest a link. Health Canada is considering updating the Canadian product monographs for these products to mention that cases of decreased breast milk production have been reported.

Summary Safety Review - Levonorgestrel-releasing intrauterine systems

Solu-Medrol Act-O-Vial 40 mg

Solu-Medrol Act-O-Vial 40 mg is the only formulation of methylprednisolone in Canada that contains bovine-sourced lactose as an excipient. Serious allergic reactions have been reported in patients allergic to cow's milk proteins who were treated with Solu-Medrol Act-O-Vial 40 mg. Solu-Medrol Act-O-Vial 40 mg is contraindicated in patients with a known or suspected hypersensitivity to cow's milk. The Canadian product monograph has been updated to reflect this new safety information.

Health Professional Risk Communication - Solu-Medrol Act-O-Vial 40 mg

Thermography devices

Health Canada reminded Canadians that thermograms (which use thermal imaging) are not a substitute for mammograms used for routine monitoring and screening for breast cancer. While thermography devices are available in Canada, these devices have not been licensed in Canada to screen for breast cancer.

Information Update - Thermography devices

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 - Multiple unauthorized health products

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