Pub. no 160256
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
Pharmaceuticals and Biologics
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:
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 email@example.com 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).