Public Advisory – Unauthorized Korean-labeled Festal Plus pills seized at GD Health Town in Coquitlam, British Columbia may pose serious health risks

OTTAWA, ON, June 28, 2024 /CNW/ –

summary

• Product: Festal Plus tablets (labeled in Korean)

• Edition: Health Products – Product Safety; Unauthorized product

• What to do: Do not use this product. Consult a healthcare professional if you have used this product and have any health concerns. Read product labels to verify that health products are approved for sale by Health Canada. Only purchase prescription drugs from licensed pharmacies. Return products to your local pharmacy for proper disposal.

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Edition

Health Canada warns consumers not to use unauthorized Festal Plus tablets confiscated from GD Health Town, Coquitlam (329 North Road #215), BC because the product label states that it contains a prescription drug (ursodiol) and may pose a serious health risk.

The unauthorized product is promoted for use in adults and children eight years of age and older who have gastrointestinal problems that make it easier to digest food; however, ursodiol is a prescription drug Canada and is only approved for the treatment of certain liver diseases.

Sale of unauthorized health products in Canada is illegal. Unauthorized health products have not been approved by Health Canada, which means they have not been evaluated for safety, effectiveness and quality and can pose a number of serious health risks. For example, they may contain high-risk ingredients, such as prescription drugs, additives or contaminants, which may or may not be listed on the label. These ingredients may interact with other medications and foods. In addition, these products may not actually contain the active ingredients that consumers would expect to help them maintain and improve their health. The product is also not labeled in both English and French, as required by the Canada.

Prescription medications should only be used on the advice and supervision of a healthcare professional because they are used to treat specific conditions and may cause serious side effects. Prescription drugs can only be legally sold to consumers in Canada with prescription.

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What should you do

• Do not use this product. If you have used this product and have health problems, please consult your healthcare professional.

• Return the product to your local pharmacy for proper disposal.

• Purchase prescription medications from licensed pharmacies.

• Buy only authorized health products. Read product labels to see if the health products are approved for sale by Health Canada. Approved health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN), or Homeopathic Medicine Number (DIN-HM). You can also check if the products are approved for sale by searching the Health Canada Drug Products Database and the Licensed Natural Health Products Database.

• Report any side effects or complaints related to health products to Health Canada.

Background

Ursodiolalso known as ursodeoxycholic acid, is a prescription drug used to treat cholestatic liver disease (diseases in which there is blocked or reduced flow of bile from the liver). Serious side effects of taking ursodeoxycholic acid include allergic reactions, chest pain and difficulty breathing, abdominal pain, nausea, diarrhea or constipation, swelling of the extremities (e.g. hands and feet), high blood pressure, fatigue, dizziness, headache, itching, fever and jaundice. Some patients have experienced additional symptoms such as vomiting and abdominal pain due to blockages in the digestive tract, requiring medical intervention. Blood tests are necessary to monitor the risk of liver toxicity from taking this medicine. Ursodeoxycholic acid should not be used by people who are allergic to ursodiol, have blocked bile flow due to liver or other disease, or people who are pregnant, planning to become pregnant or breastfeeding.

Également available in French

SOURCE Health Canada (HC)

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