Health Product InfoWatch - May 2018

Contents

• Health products mentioned in this issue
• Announcement: New regulations to provide better information for patients on the safe use of opioid medications
• Monthly recap
• New information
  • Product monograph update: Dipeptidylpeptidase-4 (DPP-4) Inhibitors
  • Product monograph update: Elavil (amitriptyline hydrochloride)
  • Product monograph update: Gadolinium-Based Contrast Agents
  • Product monograph update: Imitrex injection (sumatriptan succinate)
  • Product monograph update: Revlimid (lenalidomide)
  • Product monograph update: Zydelig (idelalisib)
  • Notice of Market Authorization with Conditions: Bavencio (avelumab)
  • Notice of Market Authorization with Conditions: Imfinzi (durvalumab)
• Scope
  • Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

Pharmaceuticals and Biologics

• Atypical antipsychotics
• Bavencio (avelumab)
• Bortezomib for Injection
• Dipeptidylpeptidase-4 (DPP-4) Inhibitors
• Elavil (amitriptyline hydrochloride)
• EpiPen and EpiPen Jr (epinephrine)
• Erfa-Tranexamic 100 mg/mL
• Gadolinium-Based Contrast Agents
• Imfinzi (durvalumab)
• Imitrex injection (sumatriptan succinate)
• Oral contraceptives
• Primidone
• Revlimid (lenalidomide)
• Sevoflurane
• Zydelig (idelalisib)

Medical Devices

• Percutaneous Radiofrequency Ablation Catheters

Natural Health Products

• “Organic Traditions Shatavari Powder”
• “Throat Coat Lemon Echinacea” herbal tea

Other

• Foreign health products
• Unauthorized health products

Announcement

New regulations to provide better information for patients on the safe use of opioid medications

Health Canada has published new regulations in Canada Gazette, Part II that will now make warning stickers and patient information handouts mandatory with prescription opioids dispensed at pharmacies or in doctor’s offices across Canada.

The warning sticker will be applied to the container being dispensed to the patient.

The patient handout will include important information about the signs of opioid overdose, safe storage and other warnings.

The mandatory warning sticker and the patient handout will begin to be distributed in October 2018.

The new regulations will also require pharmaceutical companies to develop and implement mandatory risk management plans to help characterize, monitor, prevent and manage risks associated with the use of their opioid products.

• News Release
• Regulations Amending the Food and Drug Regulations (Opioids)

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 April 2018 by Health Canada.

Atypical antipsychotics

This safety review evaluated the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with atypical antipsychotics. Health Canada's review followed the manufacturers’ voluntary update of the product safety information for Zyprexa (olanzapine) and Zeldox (ziprasidone) to include the risk of DRESS. Health Canada’s review of the available information concluded that there may be a link between the risk of DRESS and the use of 6 other atypical antipsychotics including aripiprazole, clozapine, lurasidone, paliperidone, quetiapine and risperidone. Health Canada will work with the manufacturers to update the Canadian product monographs for these atypical antipsychotics to include the risk of DRESS.

Summary Safety Review – Atypical antipsychotics

Bortezomib for Injection

Teva Canada Inc. has recalled Bortezomib for Injection 3.5 mg/vial, lot 9501016, due to the potential for the presence of particulate matter (glass).

Drug recall – Bortezomib for Injection

EpiPen and EpiPen Jr (epinephrine)

Following Health Canada’s previous communication regarding a shortage of EpiPen (0.3 mg) auto-injectors, this update provides further information on the EpiPen and EpiPen Jr (0.15 mg) shortages.

Information Update – EpiPen and EpiPen Jr (epinephrine)

Erfa-Tranexamic 100 mg/mL

ERFA Canada 2012 Inc. has recalled Erfa-Tranexamic 100 mg/mL (50 mL), lot P146A, due to the presence of particulate matter.

Drug recall – Erfa-Tranexamic 100 mg/mL 

Foreign health products

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

Oral contraceptives

Health Canada recently communicated about instances of quality concerns involving Alesse and Alysena oral contraceptives. Health Canada continues to receive complaints of quality issues and reminds women to always check their pills before taking them. If anything unusual is noticed, such as missing or damaged pills, the package should be returned to the pharmacy for replacement as soon as possible.

Advisory – Oral contraceptives  

“Organic Traditions Shatavari Powder”

One lot of “Organic Traditions Shatavari Powder” is being recalled by Advantage Health Matters Inc. Company testing found Salmonella bacteria contamination. The product is promoted as an Ayurvedic herbal tonic to support general health.

Advisory – "Organic Traditions Shatavari Powder"

Percutaneous Radiofrequency Ablation Catheters

This safety review evaluated the risk of atrioesophageal fistula associated with percutaneous radiofrequency ablation catheters. Health Canada’s review concluded that there is a potential link. This risk is not specific to any one device or manufacturer. Health Canada will work with the manufacturers of these catheters to update the Instructions for Use to include this safety information. Health Canada has also communicated this information to healthcare professionals.

• Summary Safety Review – Percutaneous Radiofrequency Ablation Catheters
• Health Professional Risk Communication – Percutaneous Radiofrequency Ablation Catheters

Primidone

AA Pharma Inc. recalled 2 lots of Primidone tablets because they contain high levels of lead. The company has indicated that only the lots identified in the advisory (lot number MT4040 and MM3274) are affected by this issue.

Advisory – Primidone
Drug recall – Primidone

Sevoflurane

This safety review evaluated the risk of bradycardia associated with sevoflurane, in children with Down syndrome. Health Canada’s review concluded that there is a link. Health Canada has recommended that the manufacturers of sevoflurane products strengthen the existing Canadian product monographs to include the data reported in published studies about this risk in children with Down syndrome.

Summary Safety Review – Sevoflurane

“Throat Coat Lemon Echinacea” herbal tea

One lot of “Throat Coat Lemon Echinacea” herbal tea was recalled by Traditional Medicinals after a company supplier found Salmonella contamination in a tea ingredient (lemon myrtle leaf). The recalled product was sold at stores across Canada and online, including Amazon Canada, Bulk Barn, Loblaws, London Drugs and Walmart.

Advisory – “Throat Coat Lemon Echinacea” herbal tea

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.

Update – Multiple unauthorized health products