Health Product InfoWatch - February 2017
ISSN 2368-8025
Pub. no 160256
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
Contents
- Announcement
- Monthly recap
- New information
- Review article: Colorectal stents and bevacizumab: increased risk of intestinal perforation
- Vaccine safety quarterly summary: Report for April 1, 2016 to June 30, 2016
- Product monograph update: Tramadol-containing products
- Product monograph update: Votrient (pazopanib)
- Product monograph update: Zyprexa (olanzapine)
Health products mentioned in this issue
Pharmaceuticals and Biologics
- Amiodarone (intravenous)
- Bevacizumab
- Charac and Charac-Tol activated charcoal products
- Erwinase (Erwinia L-asparaginase)
- Fluoroquinolones
- Gadolinium-based contrast agents (GBCAs)
- Human chorionic gonadotropin (hCG)
- Levetiracetam
- Oral retinoid products
- Selective serotonin reuptake inhibitors (SSRIs)
- Tramadol-containing products
- Votrient (pazopanib)
- Zyprexa (olanzapine)
Medical Devices
Other
Announcement
Misleading advertising of human chorionic gonadotropin (hCG) products for weight loss
Health Canada has become aware that the Web sites of several weight loss clinics promote specific hCG prescription products for weight loss. Advertising of hCG prescription products for weight loss contravenes the Federal Food and Drugs Act and Regulations and may contravene provincial/territorial laws in some jurisdictions.
Health Canada would like to remind healthcare professionals of the following information:
- There are no hCG prescription products authorized by Health Canada for weight loss treatment.
- The promotion of such an unauthorized claim/benefit is considered to be off-label promotion, which is in contravention of the Food and Drugs Act.
- Health Canada is not aware of any substantial scientific evidence that hCG is effective for weight loss, that it redistributes fat, or that it reduces appetite or the hunger and discomfort associated with calorie-restricted diets.Footnote *
Within the past month, Health Canada has identified more than 20 clinics across the country engaging in misleading advertising. Please report complaints about hCG products being promoted for weight loss to Health Canada at mhpd_dpsc@hc-sc.gc.ca or 613-793-6922, or visit the Regulatory Advertising Web site for more information.
Health Canada assesses all advertising complaints it receives to confirm whether the advertising materials comply with the applicable legislation and regulations, and takes appropriate action to address complaints where non-compliance is found. These advertising complaints are published on the Health Canada Web site in a summary table.
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 January 2017 by Health Canada.
Amiodarone (intravenous)
This safety review evaluated the risk of adverse reactions in fetuses and newborns associated with the use of amiodarone. Health Canada’s review concluded that there may be a link between amiodarone use during pregnancy or in newborns and the risk of cardiac adverse reactions. Health Canada has requested that manufacturers update the Canadian product monographs for intravenous amiodarone products to include this risk.
Charac and Charac-Tol activated charcoal products
Health Canada advised Canadians that 4 lots of activated charcoal products were recalled by the company Omega Laboratories Ltd. because they may pose health risks. The company has confirmed that 2 lots have microbial contamination and is recalling the other 2 lots as a precaution.
Erwinase (Erwinia L-asparaginase)
Small amounts of particulate matter have been observed bound to the stopper and/or present on the lyophilized cake of some vials of Erwinase from BATCH 179G. Vials of Erwinase with visible particulate matter must not be administered. To avoid potential shortage, Health Canada has facilitated the temporary importation of UK-labelled product from Batch CAMR-179G. If there is no visible particulate matter after reconstitution, a standard 5-micron filter needle should be used to withdraw the reconstituted product from the vial prior to administration. Healthcare professionals should refer to the Erwinase Canadian product monograph for prescribing information.
Fluoroquinolones
This safety review evaluated the risk of disabling and persistent serious adverse reactions including tendinopathy, peripheral neuropathy, and central nervous system disorders associated with fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin). Health Canada's review concluded that some of the known adverse reactions, specifically tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders, may be persistent and/or disabling. These adverse reactions are considered rare. Health Canada is working with manufacturers to update the Canadian product monographs of all systemic fluoroquinolone products to include this risk. Health Canada is working with the Drug Safety and Effectiveness Network (DSEN) and the Canadian Agency for Drugs and Technologies in Health (CADTH) to conduct additional studies to better understand the use of fluoroquinolones in Canada. Health Canada has also communicated this information to healthcare professionals and to Canadians.
Summary Safety Review – Fluoroquinolones
Health Product Risk Communication – Fluoroquinolones
Information Update – Fluoroquinolones
Foreign health products
These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients or heavy metals (lead). 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.
Gadolinium-based contrast agents (GBCAs)
Health Canada conducted a safety review of gadolinium-based contrast agents (GBCAs) due to growing scientific evidence that gadolinium may accumulate in the brain following multiple contrast-enhanced magnetic resonance imaging (MRI) scans. Although no health consequences have been identified with gadolinium accumulation in the brain, Health Canada will be working with Canadian manufacturers to update the Canadian product monographs of GBCAs to include this new information.
Human chorionic gonadotropin (hCG)
Health Canada informed Canadians that human chorionic gonadotropin (hCG) is not authorized as a weight loss aid, and could pose serious health risks. Health Canada has received several complaints that clinics across Canada are advertising hCG for weight loss, which is an unauthorized use.
Levetiracetam
This safety review evaluated the risk of acute kidney injury associated with levetiracetam (Keppra and generics). Health Canada's review concluded that there may be a link. The current Canadian product monograph for Keppra informs that cases of acute kidney injury have been reported in patients treated with levetiracetam. Health Canada has requested that the other manufacturers of levetiracetam-containing products also update their Canadian product monographs with the same wording.
Oral retinoid products
This safety review evaluated the risk of erectile dysfunction associated with oral retinoid products (isotretinoin, tretinoin, alitretinoin and acitretin). Health Canada’s review concluded that there may be a link between the use of oral isotretinoin products and the risk of erectile dysfunction, but could not draw the same conclusion for the other drugs in the class. Health Canada recommended that the Canadian product monographs for all isotretinoin products be made consistent to include this risk.
Selective serotonin reuptake inhibitors (SSRIs)
This safety review evaluated the risk of autism spectrum disorders associated with selective serotonin reuptake inhibitors, or SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline). Health Canada's review found that the available evidence is not strong enough to conclude that SSRI use during pregnancy can cause autism in exposed children. Health Canada will continue to monitor this issue.
Unauthorized health product (Blow)
Health Canada advised Canadians that it seized the unauthorized health product “Blow,” by Limitless Pharma, from Atomik Nutrition in Boucherville, Québec. “Blow” is promoted as a pre-workout supplement and is labelled to contain the unauthorized drug 1,3 Dimethylamylamine (DMAA), which may pose serious health risks such as high blood pressure and stroke.
Unauthorized health products (Animal PM, Blade, and Rich Piana 5% Nutrition – 5150)
Health Canada advised Canadians that it seized three unauthorized workout supplements from various Canadian retailers. “Animal PM” is labelled to contain L-dopa while “Blade” is labelled to contain yohimbine. "Rich Piana 5% Nutrition – 5150" is labelled to contain a combination of synephrine and caffeine.
Unauthorized health products (poppers and sexual enhancement products)
Health Canada advised Canadians that it seized unauthorized health products being sold at
24 Hour Adult Mart in Toronto, Ontario. Three of the seized products are “poppers” (Rush, Ram and The Original Jungle Juice Platinum) labelled to contain alkyl nitrites. These can be dangerous if inhaled or ingested. The other seized products are promoted for sexual enhancement and labelled to contain drugs that may pose serious health risks (DHEA, pregnenolone, and yohimbe/yohimbine).
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