Warning - OTC diet supplement contains undeclared diet drug

Aug 21 2007

Canadians are being warned that an over-the-counter (OTC) dietary supplement has been recalled because it contains a prescription drug used in the treatment of obesity.

Health Canada says Metabolism Apple Cider Vinegar has the undeclared drug ingredient sibutramine, an appetite suppressant.

Metabolism Apple Cider Vinegar is sold in the United States and is also distributed in Canada and the manufacturer, Confidence Inc., has confirmed that some of the affected bottles have been distributed in Canada where the products are not authorized for sale.

The Food and Drug Administration (FDA) in the U.S. informed the company that lab analysis of Metabolism samples found that the product contains undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss.

The FDA has not approved Metabolism as a drug and says therefore the safety and effectiveness of this product is unknown.

Health Canada is working with the importer to determine where the product was sold and to ensure that it is immediately removed from the market.

The recalled product carries the lot number 3001006, EXP. 102009 and UPC CODE: 92483 00102; it comes in a plastic bottle with white and red labelling containing 60 gelatin capsules.

This lot was primarily sold in Canada.

Sibutramine can cause serious side-effects, including cardiovascular reactions such as increased blood pressure, chest pain, and stroke and the drug may also interact with a number of other medications.

People taking sibutramine must be monitored by a doctor as the drug should not be taken by people who have had a heart attack, coronary artery disease, heart-related chest pain, irregular heart beats, congestive heart failure, a stroke or symptoms of a stroke.

Those with unstable or poorly controlled high blood pressure, or who are depressed or suffering from have a psychiatric illness, should not take the drug, along with women who are pregnant, breastfeeding or planning to become pregnant.

Consumers with the recalled product are asked to immediately discontinue its use and consult their doctor if they have concerns.

They should return the product to the point of purchase.

To date no illnesses or injuries have been reported to the company in connection with this product.