Unauthorized products may pose serious health risks (November 17, 2017 to May 23, 2018)

Starting date:

November 17, 2017

Posting date:

May 23, 2018

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products

Audience:

General Public

Identification number:

RA-65132

Last updated:
2018-06-08

• 
  Issue
• 
  What you should do
• 
  Background
• 
  Affected products
• 
  Related AWRs
• 
  Media enquiries
• 
  Public enquiries
• 
  Images

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.

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

Arecoline, hordenine, huperzine and high levels of caffeine can cause serious side effects ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and stroke. In addition, caffeine consumption by pregnant women is linked to a variety of negative birth outcomes such as spontaneous abortion, pre-term delivery, birth defects, and delayed fetal growth or delayed development following birth.

Caffeine and synephrine, when combined, may cause serious and possibly fatal adverse effects. Synephrine taken in combination with caffeine can cause side effects ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and stroke.

Dapoxetine is a drug used to treat premature ejaculation and is not authorized for sale in Canada. Side effects include fainting or loss of consciousness, dizziness, changes in blood pressure, blurred vision, seizures, headache, diarrhea and nausea. In particular, dapoxetine should not be used by individuals who have cardiac conditions, liver disease, a history of mania or bipolar disorder, or are taking certain other medications, including monoamine oxidase inhibitors, antidepressants, and a number of other drugs and herbal products that can interact with dapoxetine.

Desmethyl carbodenafil is an unauthorized substance similar to sildenafil and may pose similar health risks.

Dithiodesmethyl carbodenafil is an unauthorized substance similar to sildenafil and may pose similar health risks.

Glibenclamide (also known as glyburide) is a prescription drug that is used to lower blood sugar. Inappropriate exposure may result in a dangerous drop in blood sugar. A significant drop in blood sugar can cause convulsions or loss of consciousness and can be life-threatening. The risk of a drop in blood sugar is higher in nondiabetic individuals or in diabetic patients taking anti-diabetic medications.

Hydroxythiohomosildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks.

L-Dopa, also known as levodopa, is a prescription drug that is combined with other drug ingredients in anti-Parkinson's medications. It should be used only under the supervision of a health care professional. Levodopa may interact with drugs prescribed for high blood pressure, and should not be used by women who are pregnant, who plan to become pregnant or who are breastfeeding. It should also not be taken by people with narrow angle glaucoma; untreated heart, liver, kidney, lung or hormonal diseases; a history of melanoma; or those who should not take drugs such as isoproterenol, amphetamines or epinephrine. Side effects requiring medical attention include: uncontrollable movements of the face, eyelids, mouth, tongue, neck, arms, hands, or legs; severe or persistent nausea or vomiting; an irregular heartbeat or fluttering in the chest; feeling lightheaded when standing quickly; or unusual changes in mood or behaviour.

"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 health care 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. Bodybuilding products that contain SARMs are associated with serious safety concerns, including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage.The long-term effects on the body are unknown. Examples include andarine, ostarine, LDG 4033, and RAD-140. Other unauthorized drugs promoted for fitness and bodybuilding include: MK-677, SR-9009 and cardarine. Cardarine (also known as GW501516 and possibly GW1516) is not authorized in Canada for any use. 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.

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.

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.

Tetracaine is a local anesthetic applied on the skin, and may cause adverse effects such as allergic reactions as well as nervousness, agitation, restlessness and muscle twitching. Rarely, high doses of tetracaine could cause seizures, respiratory arrest, cardiac arrhythmias (irregular heart rhythm), blood pressure instability, and even cardiac arrest.

Thiodimethylsildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks.

Thyroid is a prescription drug ingredient commonly used to treat decreased or absent thyroid function, called hypothyroidism. Products containing thyroid hormone should be used with caution in patients also using medication to treat diabetes and blood clotting. There is also a risk to patients with cardiac conditions such as angina pectoris, high blood pressure and in the elderly as they have a greater likelihood of heart conditions.

Vardenafil 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.

Zopiclone is a prescription drug used to treat insomnia. Side effects associated with zopiclone include unpleasant taste, drowsiness, dizziness, memory loss and hallucinations.

Affected products

Related AWRs

Media enquiries

Health Canada

(613) 957-2983

Email: hc.media.sc@canada.ca

Public enquiries

(613) 957-2991

1-866 225-0709

Images

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