Friday, May 17, 2019

Unauthorized products, Natural health products, may pose serious health risks - Health Canada Advisory




Unauthorized products may pose serious health risks (May 17, 2019 - Part 2)

Starting date:
May 17, 2019
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-69977

Last updated: 


Issue

Health Canada is advising Canadians about unauthorized health products that may pose serious health risks. The table below is updated when Health Canada finds unauthorized health products that are promoted for sexual enhancement, weight loss, as a workout aid, or as “poppers,” and that are labelled to contain or have been tested and found to contain dangerous ingredients. Links to previous tables with affected products are also available below.
Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, effectiveness and quality. Unauthorized health products can pose many health dangers, including:
  • They may contain ingredients not listed on the label. This includes ingredients like prescription drugs, possibly at doses exceeding maximum recommended amounts. Prescription drugs should be taken only under the supervision of a health professional because they may cause serious side effects. Using a product that contains ingredients that the consumer is not aware of increases the chance of dangerous allergies and interactions with other medications and foods.
  • The label may indicate a dangerous ingredient or combination of ingredients. For example, it could list a drug that should be available only by prescription from a heath care professional, or a combination of ingredients that Health Canada does not permit because of serious health risks.
Health Canada maintains this page so that Canadians can easily identify products they may have purchased and take appropriate action. Canadians are encouraged to check back regularly for updates. Advisories on safety issues involving other types of products are available in the recalls and safety alerts database.

What you should do

  • Stop using the products listed below. Consult your health care professional if you have used these products and have health concerns, and for advice on which health products are best for you and your family.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check if products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.
  • Report any health product adverse events or complaints to Health Canada.
  • See the additional information on buying health products safely in the helpful links below.

What companies should know:

  • Selling unauthorized health products in Canada is illegal.
  • When Health Canada identifies unauthorized products that may pose serious health risks, Health Canada takes appropriate action to prevent further distribution and informs Canadians. This includes working with the Canada Border Services Agency to help prevent further importation of unauthorized products.

Background

Cardarine (also known as GW501516 and possibly GW1516), MK-677 and SR-9009 are not authorized in Canada for any use and may pose serious health risks. All clinical development of GW501516 was stopped when toxicities, including various cancers, were discovered following routine, long-term animal studies. The long-term effects in humans are unknown.
Dimethylamylamine (DMAA) is a drug that is not authorized for use in Canada. Side effects include high blood pressure, shortness of breath, chest pain, stroke and psychiatric disorders.
Chloramphenicol is a prescription antibiotic drug. It is associated with a rare risk of aplastic anemia, a serious blood disorder that can be fatal. This reaction is unpredictable and not related to a specific dose of chloramphenicol. Other side effects include allergic reactions in people who have sensitivity to the medication, and effects on the bone marrow leading to decreased blood cells. The drug should not be used by pregnant or nursing women.
"Poppers" is a slang term for products that contain alkyl nitrites. Despite being labelled for various uses such as leather cleaners, room odourizers or liquid incense, these products are inhaled or ingested by consumers for recreational purposes. Alkyl nitrites, such as amyl nitrite, butyl nitrite and isobutyl nitrite, are prescription drugs and should be used only under the supervision of a healthcare professional. Products containing alkyl nitrites may pose serious risks, including death, depending on the amount used, how frequently they are used and how long they are used for, as well as the person's health and the other medications they may be taking. Since it is difficult to control how much is inhaled, people can accidentally overdose. Swallowing these products can lead to serious medical complications and may be fatal. People with certain medical conditions (including recent head trauma, bleeding into the head, glaucoma, or heart disease) and those taking certain medications (particularly drugs used to treat erectile dysfunction, and other drugs such as high blood pressure medications, certain migraine drugs, and high doses of aspirin) or illicit drugs are at particular risk.
Rauwolfia (also known as rauvolfia) is a prescription drug that can be used to treat high blood pressure (hypertension). People with heart conditions or psychiatric disorders should receive close medical supervision when using it as it can make certain conditions, such as depression, worse. Common side effects include tiredness, sleepiness, depression, nasal obstruction and breathlessness. Rauwolfia should not be used by children, or pregnant or nursing women.
Selective Androgen Receptor Modulators (SARMs) are drugs that are not authorized in Canada for any use and have not been reviewed by Health Canada for safety, effectiveness and quality. The use of bodybuilding products that contain SARMs can pose serious health risks such as heart attack, stroke and liver damage. The long-term effects on the body are unknown. Examples include andarine, ostarine, LDG-4033, YK-11, and RAD-140.
Sildenafil is a prescription drug used to treat erectile dysfunction and should be used only under the supervision of a health care professional. It should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other possible side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss. The following are unauthorized substances that are similar to sildenafil and may pose similar health risks: desmethyl carbodenafil, dithiodesmethyl carbodenafil, homosildenafil, hydroxythiohomosildenafil, and thiosildenafil.
Tadalafil is a prescription drug used to treat erectile dysfunction and should be used only under the supervision of a health care professional. It should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other possible side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.
Yohimbine is a prescription drug and should be used only under the supervision of a health care professional. Yohimbine is derived from yohimbe, a bark extract. The use of yohimbine or yohimbe may result in serious adverse reactions particularly in people with high blood pressure, or heart, kidney or liver disease. Side effects include increased blood pressure and heart rate, anxiety, dizziness, tremors, headache, nausea and sleep disorders. It should not be used by children, or pregnant or nursing women.

Affected products

See table Part 1 and Part 2 below. Links to previous tables with affected products are also available below.

Product description

Unauthorized health products
PhotoProduct &
Promoted Use
Hazard IdentifiedCompanyAction TakenDate Added
Blue Rhino 10000Blue Rhino 10000 
Sexual enhancement
Labelled to contain yohimbeLucky Star Convenience
1060 Kennedy Rd,
Scarborough, ON
Seized from the retail locationMay 17, 2019
Stiff RoxStiff Rox 
Sexual enhancement
Product with similar packaging previously seized was tested and found to contain sildenafil and tadalafilLucky Star Convenience
1060 Kennedy Rd,
Scarborough, ON
Seized from the retail locationMay 17, 2019
Black PantherBlack Panther
Sexual enhancement
Labelled to contain yohimbeMidland Jug Milk
2516 Eglinton Ave E,
Scarborough, ON
Seized from the retail locationMay 17, 2019
Ginseng Red 2000Ginseng Red 2000
Sexual enhancement
Product with similar packaging previously seized was tested and found to contain sildenafilMidland Jug Milk
2516 Eglinton Ave E,
Scarborough, ON
Seized from the retail locationMay 17, 2019
Hard Rock 3800Hard Rock 3800 
Sexual enhancement
Labelled to contain yohimbeMidland Jug Milk
2516 Eglinton Ave E,
Scarborough, ON
Seized from the retail locationMay 17, 2019
Master Zone 1500Master Zone 1500 
Sexual enhancement
Product with similar packaging previously seized was tested and found to contain sildenafil and tadalafilMidland Jug Milk
2516 Eglinton Ave E,
Scarborough, ON
Seized from the retail locationMay 17, 2019
Premium Pro Power 3500Premium Pro Power 3500 
Sexual enhancement
Labelled to contain yohimbe
Product with similar packaging previously seized was tested and found to contain sildenafil
Midland Jug Milk
2516 Eglinton Ave E,
Scarborough, ON
Seized from the retail locationMay 17, 2019
Super Panther 7KSuper Panther 7K 
Sexual enhancement
Labelled to contain yohimbeMidland Jug Milk
2516 Eglinton Ave E,
Scarborough, ON
Seized from the retail locationMay 17, 2019
Alien2PowerAlien2Power 
Sexual enhancement
Product with similar packaging previously seized was tested and found to contain tadalafilSujaaan Convenience
2404 Eglinton Avenue East
Scarborough, ON
Seized from the retail locationMay 17, 2019
Black Mamba PremiumBlack Mamba Premium 
Sexual enhancement
Labelled to contain yohimbeSujaaan Convenience
2404 Eglinton Avenue East
Scarborough, ON
Seized from the retail locationMay 17, 2019
Ginseng Red 2000Ginseng Red 2000 
Sexual enhancement
Product with similar packaging previously seized was tested and found to contain sildenafilSujaaan Convenience
2404 Eglinton Avenue East
Scarborough, ON
Seized from the retail locationMay 17, 2019
Premium Pro Power 3500Premium Pro Power 3500 
Sexual enhancement 
Labelled to contain yohimbe
Product with similar packaging previously seized was tested and found to contain sildenafil
Sujaaan Convenience
2404 Eglinton Avenue East
Scarborough, ON
Seized from the retail locationMay 17, 2019
Rush Hour 72Rush Hour 72 
Sexual enhancement
Product with similar packaging previously seized was tested and found to contain  sildenafiltadalafildesmethyl carbodenafil, and dithiodesmethyl carbodenafilSujaaan Convenience
2404 Eglinton Avenue East
Scarborough, ON
Seized from the retail locationMay 17, 2019
Super Panther 7KSuper Panther 7K
Sexual enhancement
Labelled to contain yohimbeSujaaan Convenience
2404 Eglinton Avenue East
Scarborough, ON
Seized from the retail locationMay 17, 2019
Victorious Premium EditionVictorious Premium Edition
Sexual enhancement
Product with similar packaging previously seized was tested and found to contain  hydroxythiohomosildenafilSujaaan Convenience
2404 Eglinton Avenue East
Scarborough, ON
Seized from the retail locationMay 17, 2019
XXLant 3000XXLant 3000 
Sexual enhancement
Labelled to contain yohimbeSujaaan Convenience
2404 Eglinton Avenue East
Scarborough, ON
Seized from the retail locationMay 17, 2019


Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

Images

Select thumbnail to enlarge
Blue Rhino 10000
Stiff Rox
Black Panther
Ginseng Red 2000
Hard Rock 3800
Master Zone 1500
Premium Pro Power 3500
Super Panther 7K
Alien2Power
Black Mamba Premium
Ginseng Red 2000
Premium Pro Power 3500
Rush Hour 72
Super Panther 7K
Victorious Premium Edition
XXLant 3000

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