Wednesday, December 12, 2018

Unauthorized Natural Health Products May Pose Serious Health Risks -Health Canada

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 Unauthorized products may pose serious health risks


Starting date:
December 10, 2018
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-68576

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.
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. Bodybuilding products that contain SARMs are associated with serious safety concerns, including potential increased risk of heart attack or stroke and life threatening reactions such as liver damage. The long-term effects on the body are unknown. Examples include andarine, ostarine, LDG-4033, and RAD-140.

Affected products

See table here. Links to previous tables with affected products are also available below.

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