Unauthorized products may pose serious health risks (October 2, 2019 to November 19, 2019)

Starting date:

October 2, 2019

Posting date:

November 19, 2019

Type of communication:

Advisory

Subcategory:

Drugs, Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Important Safety Information

Audience:

General Public

Identification number:

RA-71157

Last updated: 2019-12-09

• Issue
• What you should do
• Background
• Affected products
• Related AWRs
• 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. 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 care 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 health 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

Androsta-3,5-diene-7,17-dione is a drug of the aromatase inhibitor class that claims to improve muscle mass and strength. This drug prevents the conversion of testosterone to estrogen. Little is known about its effects as there are no studies in patients, but other similar banned anabolic‐androgenic steroids cause long‐term health effects. Side effects associated with the use of similar drugs include decreased bone growth, decreased sperm production, infertility, aggressive behaviour, adrenal insufficiency, kidney failure, and liver dysfunction. People who have diabetes, psychiatric, heart, liver or kidney disease may be at greater risk.

Boldenone undecylenate is an anabolic steroid, a synthetic derivative of testosterone, and poses similar health risks as testosterone compounds. It was previously used as a veterinary medicine in Canada but was removed from the market.

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.

Cardarine (also known as GW501516 and GW1516), MK-677 and SR-9009 are not authorized in Canada for any use and may pose serious health risks. All clinical development all activities to bring GW501516 to market were stopped when toxicities, including various cancers, were discovered following routine, long-term animal studies. The long-term effects in humans are unknown.

Dehydroepiandrosterone (DHEA) is a controlled substance that can cause higher-than-normal levels of female and male hormones in the body and could increase the risk of prostate, breast, ovarian and other hormone-sensitive cancers. Potential side effects include serious cardiovascular disease, and changes in fertility and sperm production. DHEA should be avoided by individuals with a history of abnormal heart rhythms, blood clotting disorders, liver disease and those who are pregnant or breastfeeding.

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.

Drostanolone proprionate is an anabolic steroid, a synthetic derivative of testosterone, and is not authorized for sale in Canada. It was previously used in the United States to treat breast cancer in women but it was removed from the market. Side effects include acne, elevated blood pressure, changes in lipids (blood fat levels), adverse cardiac effects, mood changes, decreased testicle size, and temporary infertility and libido (sex drive) changes. In women, it can cause male characteristics such as an increase in facial hair growth, male pattern baldness, deepening of the voice and menstrual irregularities. It should not be used by pregnant women, and by patients with high blood pressure, cardiac, liver or kidney disease, prostate cancer or by those taking blood thinners (as it can increase the risk of bleeding).

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.

Nandrolone decanoate is an anabolic steroid, a synthetic derivative of testosterone, and is not authorized for sale in Canada. Side effects include nausea; fluid retention with swelling of legs, feet and ankles; insomnia; anxiety; chills; acne and changes to libido (sex drive). In women, it can cause male characteristics such as an increase in facial hair growth, male pattern baldness, deepening of the voice and menstrual irregularities. In men, it can cause erectile difficulties, frequent or prolonged erections, decreased testicle size, increased urination, and breast enlargement. In young children, it can cause serious problems with growth and sexual development. Nandrolone decanoate can affect liver function, cholesterol levels, and increase calcium and potassium levels. It can also affect thyroid tests and glucose control in diabetic patients. Nandrolone decanoate should not be used by men with prostate or breast cancer, pregnant women, or people with cardiac or kidney failure, or liver disease. It should be used with caution by people with any other cardiac or renal diseases, male patients with benign prostate enlargement, patients with cancer and those on blood thinners (as it may increase the risk of bleeding).

Oxandrolone is an anabolic steroid, similar to male hormones (testosterone). Drugs from this class can cause serious side effects such as heart disease (including heart attack and heart failure), formation of blood-filled cysts or tumors in the liver, water retention (with swelling of ankles and feet, shortness of breath, and weight gain), kidney disease, stroke, mental health problems (including anxiety, depression, anger, trouble sleeping, abnormal drug-seeking behaviour), nausea, vomiting, headache, change in sexual interest, acne, high blood pressure, breathing problems, jaundice, high blood calcium levels (with vomiting, stomach pain, increased thirst or urination, muscle pain or weakness, joint pain), high blood fat levels, and allergic reactions (with rash, swelling of face, tongue, throat, and difficulty breathing). It may also be habit-forming. In men, side effects include trouble urinating, too frequent or prolonged erections, infertility, decrease in testicle size, enlarged prostate, breast swelling, and abnormal penis growth before puberty. In women, use may lead to male-pattern hair growth (on the chin or chest), deepening of the voice, male pattern baldness, and menstrual abnormalities. Bone growth may be affected in children.Oxandrolone should not be taken by people who are allergic to it, have prostate or breast cancer, heart disease, advanced kidney disease, high blood calcium levels, high blood fat or calcium levels, diabetes, chronic obstructive pulmonary disease, a history of stroke or blood clots and who are pregnant. Use is not recommended while breast-feeding. Oxandrolone should not be taken with other steroid medicines, blood thinners (causes bleeding) and some herbal products.

Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer. Additional side effects include decreased blood pressure, skin rash and gastrointestinal bleeding.

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 (MK 2866), LDG-4033 YK-11, and RAD-140.

Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because it’s associated with an increased risk of cardiovascular side effects, such as heart attack and stroke. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

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. Hydroxythiohomosildenafil and thiosildenafil are unauthorized substances that are similar to sildenafil and may pose similar health risks.

Somatropin is a prescription drug that contains human growth hormone. It is used to treat children or adults with stunted growth caused by their body's inability to produce sufficient amounts of natural growth hormones. It is also used to treat children with Turner syndrome or chronic renal failure. Somatropin can alter blood sugar levels and its use may require patients to monitor their blood sugar regularly. It can affect patients' thyroid hormones resulting in the need for thryoid hormone replacement. It can cause an allergic reaction that may be life threatening. In certain patients, it can cause brain swelling requiring immediate medical attention. In children, it may increase the risk of developing hip problems and childhood leukemia. Somatropin should only be used under the direct supervision of physicians experienced in the diagnosis and management of patients with these disorders.

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) since 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.

Tamoxifen is a prescription drug used to treat breast cancer. It should be used only under the supervision of a health care professional. Tamoxifen should not be used by pregnant women. Serious side effects include uterine cancers, stroke, blood clots, cataracts or damage to the retina of the eye, muscle pain, bone pain, increased blood calcium, and severe skin rashes or allergic reactions. Other side effects include nausea, vomiting, fatigue, fluid retention, vaginal bleeding, hot flashes, anemia, uterine fibroids (noncancerous growths), bald spots, and fatty liver.

Testosterone compounds, such as testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, testosterone canoate, testosterone enanthate, and testosterone decanoate, are anabolic steroids, synthetic derivatives of testosterone. They have been linked to many significant health risks, some of which are permanent and even fatal. Side effects include heart disease (including heart attack, heart failure, high blood pressure and stroke); water retention (with swelling of ankles and feet, shortness of breath, and weight gain); mental health problems (including anxiety, depression, or aggressive behaviour);changes in libido (sex drive); acne; breathing problems (sleep apnea); kidney disease;high blood calcium levels (with vomiting, stomach pain, increased thirst or urination, muscle pain or weakness, or joint pain); and high blood fat levels. In addition, in men, side effects include decreased sperm production, decreased testicle size, infertility, trouble urinating, too frequent or prolonged erections, enlarged prostate, breast swelling, and unusual penis growth (before puberty). In women, it can cause male characteristics such as an increase in facial hair growth, male pattern baldness, deepening of the voice and menstrual irregularities. In children, bone growth may be affected. Use of testosterone compounds may also be habit-forming. These compounds should not be taken by people with breast or prostate cancer, heart disease, advanced kidney disease, high blood calcium or fat levels, a history of stroke or blood clots, diabetes (may cause low blood sugar) and by pregnant women (may affect the baby). Use is not recommended while breast-feeding.

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

Related AWRs

Images

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