OTTAWA, ON, Aug. 5, 2022 /CNW/ -

• Product: Unauthorized health products, including prescription drugs
• Issue: Health products – Product safety; Unauthorized product
• What to do: Do not use these products. Return them to your local pharmacy for proper disposal. Consult a health care professional if you have used any of these products and have health concerns. Buy your prescription drugs only from licensed pharmacies.

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Affected products

Health Canada seized numerous unauthorized health products from Productos Latinos El Aguila located at 42 Erie St S, Leamington, Ontario. The seized products include seven that are labelled to contain prescription drugs and may pose serious health risks.

Selling unauthorized health products in Canada is illegal. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, efficacy and quality and may pose a range of serious health risks. For example, they could contain high-risk ingredients, such as prescription drugs, additives or contaminants that may or may not be listed on the label. These ingredients could interact with other medications and foods. In addition, the product may lack the active ingredients Canadians would expect them to contain to help maintain and improve their health.

Prescription drugs should only be used under the advice and supervision of a health care professional because they are used to treat specific conditions and may cause serious side effects. Prescription drugs can only be legally sold with a prescription.

If any new health risks are identified, Health Canada will take action and inform Canadians as needed. 

• Do not use these products. Return the product to your local pharmacy for proper disposal. Consult a health care professional if you have used any of these products and have health concerns.
• Buy your prescription drugs only from licensed pharmacies.
• 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 whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
• Report any health product-related side effects or complaints to Health Canada.

Ampicillin and amoxicillin are prescription antibiotic drugs used to treat certain bacterial infections. They should be used only under the supervision of a health care professional. Ampicillin and amoxicillin may cause severe allergic reactions with symptoms including swollen lips, face, throat, difficulty breathing, severe skin rashes and itchiness, nausea, vomiting, diarrhea, and signs of kidney and liver failure. They should not be used by patients with known allergies to these drugs. Patients with allergies to other antibiotic types may also experience allergic reactions to ampicillin and amoxicillin. Misuse or overuse could lead to growth of bacteria that will not be killed by ampicillin and amoxicillin and means that they may not work in the future when required (this is known as antibiotic resistance). 

Betamethasone dipropionate is a highly potent corticosteroid prescription drug that can be used topically (applied onto the skin) to treat inflammatory skin conditions. It should be used only under the supervision of a health care professional. Side effects from topical use include skin irritation, and when used for a long time, thinning and breaking down of the skin. The drug can be absorbed through the skin in sufficient amounts to cause adverse effects, including changes in blood pressure, blood sugar and weight, muscle pain, muscle weakness, bone loss, digestive tract problems, and severe fatigue. Betamethasone dipropionate should not be used by patients who are pregnant or breastfeeding.

Diclofenac for oral consumption is a prescription non-steroidal anti-inflammatory drug (NSAID) used to relieve the pain and swelling caused by arthritis. It should be used only under the supervision of a health care professional. It increases the risk of serious heart-related events (such as heart attack and stroke), high blood pressure, stomach or intestinal bleeding or ulcers, severe kidney or liver problems, and bleeding or clotting problems. It should not be used by patients who have: severe heart problems; stomach or intestinal conditions; bleeding disorders; a history of asthma or allergic-type reactions after taking acetylsalicylic acid (ASA) or NSAIDs including diclofenac; severe kidney or liver problems; or high potassium in the blood. It should also not be used by children less than 16 years of age, or by patients in the third trimester of pregnancy or who are breastfeeding. Use in the first and second trimester of pregnancy must be carefully considered by a doctor and patients may require increased monitoring. Diclofenac risks may be higher for patients taking other medications, as well as elderly patients.

Enalapril maleate is a prescription drug used to treat high blood pressure and heart failure. It should be used only under the supervision of a health care professional. It may cause severe allergic reaction with symptoms including swelling of the lips, tongue or face, or difficulty in breathing, and should not be used by patients with a known allergy to this drug. Enalalapril may cause serious side effects, including low blood pressure, worsened kidney function or high blood potassium levels. Patients with a condition called hereditary angioedema or idiopathic angioedema should not take enalapril. Enalapril should also not be used during pregnancy—as it can cause injury to, or death of, the developing fetus—or during breastfeeding. Taking enalapril with other medications, including other drugs to treat high blood pressure, may increase the likelihood and severity of side effects.

Gentamicin is a prescription antibiotic drug applied topically (to the skin) to treat minor skin infections. It can cause skin redness and irritation. Prolonged use can cause fungal or bacterial infections. Gentamicin may be absorbed into the blood if applied to large areas of skin, especially if the areas are cracked or raw, which increases the risk of serious side effects. Serious side effects include allergic reactions (e.g., rash, hives, and red, swollen, blistered, or peeling skin with or without fever, trouble breathing, swelling of the mouth, face, lips, tongue or throat) and kidney and hearing damage. It should not be used in patients who are allergic to gentamicin. Gentamicin may interact with other drugs and should be used with caution with other antibiotics, anti-cancer drugs, diuretics, immunosuppressants, and NSAIDs.

Omeprazole is a prescription drug known as a proton-pump inhibitor (PPI) used to treat problems caused by too much acidity in the stomach, such as ulcers (sores) and the reflux of stomach content. It should be used only under the supervision of a health care professional. It should not be used by patients with allergies to omeprazole or similar drugs, or by patients who are taking rilpivirine. Its use in patients under 18 requires consultation with a health care professional. Omeprazole passes into breast milk and should not be used by patients who are pregnant or breastfeeding, unless its use is considered essential by a doctor. Omeprazole interferes with the absorption of vitamin B12 from food and may cause a deficiency. Omeprazole may lead to low blood magnesium, low blood calcium and low blood potassium. Rare but serious side effects of omeprazole include kidney and liver problems, fungal infections of the digestive tract, increased skin sensitivity to sunlight, severe skin reactions, and blood disorders. Using omeprazole for a long time may increase the risk of bone fractures and may cause bacterial overgrowth in the stomach. Omeprazole might interact with other medications and cause serious adverse reactions. Omeprazole risks may be higher in elderly patients.

Tetracycline is a prescription antibiotic drug used to treat certain bacterial infections. It should be used only under the supervision of a health care professional. It should not be used by people who are allergic to tetracycline or similar drugs, or who have severe kidney or liver disease. It should not be used during pregnancy, as it could cause teeth and bone changes in the fetus and serious liver damage in the mother. Tetracycline can reduce the effect of birth control pills. It should not be used by patients who are breastfeeding as tetracycline passes into breast milk and can cause tooth discolouration in the baby. Tetracycline should not be used in children under 12 years of age, as it can affect bone and cause permanent tooth discolouration. Exposure to sunlight or ultraviolet light (e.g., sunlamps) should be avoided when taking tetracycline as the drug can increase skin sensitivity and cause severe sunburn. Tetracycline might interact with other medications and cause serious adverse reactions. Misuse or overuse could lead to growth of bacteria that will not be killed by tetracycline and means that it may not work in the future when required (this is known as antibiotic resistance).

Également disponible en français

SOURCE Health Canada