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Drugs and Health Products

Health Product InfoWatch - December 2016

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ISSN 2368-8025
Pub. no 150182

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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 as well as summaries of completed safety reviews published in November 2016 by Health Canada.

Bisphosphonates

This safety review evaluated the risk of osteonecrosis of the jaw associated with oral and injectable bisphosphonates (alendronate, clodronate, etidronate, pamidronate, risedronate and zoledronate). Health Canada's review concluded that there is a higher risk with the use of intravenous bisphosphonate products compared to the oral form, especially in cancer patients. Health Canada will be working with the manufacturers to update the Canadian product monographs for bisphosphonate products.

Summary Safety Review - Bisphosphonates

DPP-4 inhibitors

This safety review evaluated the risk of gastrointestinal obstruction associated with dipeptidyl peptidase 4 (DPP-4) inhibitors (alogliptin, linagliptin, saxagliptin, sitagliptin). Health Canada's review concluded that the evidence does not support a link between the use of DPP-4 inhibitors and gastrointestinal obstruction. Health Canada will continue to monitor this issue.

Summary Safety Review - DPP-4 inhibitors

Enlite Glucose Sensor

This safety review evaluated the risk of improper glucose management associated with Enlite Glucose Sensor manufactured by Medtronic MiniMed. Health Canada's review concluded that the evidence does not suggest that there is a new safety risk associated with the Enlite Glucose Sensor at this time. Health Canada will continue to monitor this issue.

Summary Safety Review - Enlite Glucose Sensor

Foreign health products

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients or heavy metals. 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.

Foreign Product Alert

Interferon beta products

This safety review evaluated the risk of pulmonary arterial hypertension associated with interferon beta products [Interferon beta-1a (Avonex and Rebif) and interferon beta-1b (Betaseron and Extavia)]. Health Canada's review concluded that pulmonary arterial hypertension is a very rare adverse reaction to interferon beta use. Health Canada has worked with the manufacturers to include this risk in the Canadian product monographs for interferon beta products.

Summary Safety Review - Interferon beta products

Loratadine

This safety review evaluated the risk of QT interval prolongation associated with loratadine. Health Canada's review concluded that a link between the use of loratadine and QT interval prolongation could not be established. Health Canada will continue to monitor this issue.

Summary Safety Review - Loratadine

MAD Nasal Intranasal Mucosal Atomization Device

Teleflex Medical recalled certain lots of "MAD Nasal Intranasal Mucosal Atomization Device" because they may not deliver a fully atomized (fine) spray of medication. This means patients may not receive the full dose, which could reduce the medication's effectiveness. The devices are used primarily by medically trained personnel but can also be used by first responders and the general public.

Advisory - MAD Nasal Intranasal Mucosal Atomization Device

Ondansetron

This safety review evaluated the risk of birth defects associated with the use of ondansetron (Zofran and generics) during pregnancy. Ondansetron is not authorized for sale in Canada to treat nausea and vomiting in pregnant women. Health Canada's review concluded that there was not enough information to establish a link. Health Canada is working with the Drug Safety and Effectiveness Network to further investigate the extent of ondansetron use during pregnancy and the risk to the fetus. Health Canada has requested that manufacturers submit information they may have regarding this risk.

Summary Safety Review - Ondansetron

Phenylephrine and acetaminophen

This safety review evaluated the risk of interaction between phenylephrine and acetaminophen. Health Canada's review concluded that the evidence shows an interaction which may lead to an increase in the relative bioavailability of phenylephrine; however, the clinical evidence to support this interaction is insufficient. Health Canada also communicated this information to healthcare professionals.

Summary Safety Review - Phenylephrine and acetaminophen

Health Product InfoWatch - Phenylephrine and acetaminophen

Rivastigmine

This safety review evaluated the increased risk of death associated with rivastigmine (Exelon and generics). Health Canada's review did not find an increased risk of death in patients taking rivastigmine regardless of the formulation used. Health Canada has asked the manufacturers of Exelon to continue to provide information on the use of this product.

Summary Safety Review - Rivastigmine

SGLT2 inhibitors

This safety review evaluated the potential for loss of bone minerals with a risk of brittle or fractured bones associated with sodium-glucose cotransporter-2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, empagliflozin). Health Canada's review concluded that the evidence supported a link between the risks of bone fracture and loss of bone mineral density with canagliflozin. With dapagliflozin, these risks were only identified in patients who had kidney problems. No evidence was found to date with empagliflozin. Health Canada is working with the manufacturer to update the Canadian product monograph for canagliflozin to reflect these risks.

Summary Safety Review - SGLT2 inhibitors

Unauthorized health product

"Phytovie Acore Vrai Calamus" herbal tea, an unauthorized natural health product, was recalled after Health Canada testing found it to contain excessive levels of beta-asarone. The product was sold by Gourmet Nutrition F.B. Inc. over the Internet and may also be available at retail stores.

Advisory - Unauthorized health product

Zelboraf (vemurafenib)

This safety review evaluated the risk of bone marrow toxicity or suppression associated with Zelboraf (vemurafenib). Health Canada's review concluded that the current evidence available does not support a link between Zelboraf use and bone marrow toxicity or suppression. Health Canada will continue to monitor this issue.

Summary Safety Review - Zelboraf (vemurafenib)

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