Health Canada informs Canadians of Vioxx® withdrawal by Merck & Co

Main Category: Cardiovascular / Cardiology
Article Date: 07 Oct 2004 - 12:00 PST


OTTAWA - Health Canada is informing Canadians of the worldwide voluntary withdrawal of Vioxx® by Merck & Co., as announced today by the company. Merck & Co will be removing the product from the market due to new information that indicates an increased risk of cardiovascular events such as heart attacks and strokes. Health Canada advises patients taking Vioxx® to consult their physicians about discontinuing use of the product and treatment alternatives.

The company's decision comes as a result of new information received during a three-year clinical trial called APPROVe (Adenomatous Polyp Prevention Vioxx®), which studied the use of Vioxx® for the prevention of colon polyps. During the course of the trial, evidence showed an increased risk of cardiovascular events including heart attacks and strokes among study patients taking Vioxx® compared to those taking a placebo (sugar pill). The effects were specifically observed in patients who were taking the drug for more than 18 months. The clinical trial was stopped as a result of these findings.

Initial analysis of the most recent study shows that individual risk of suffering a heart attack or stroke for patients taking Vioxx® remains small. However, the risk increases with prolonged use (over 18 months). The concerns raised by the study, as well as the availability of alternative treatments, prompted Merck & Co.'s decision to withdraw the product.

Vioxx® is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) approved in Canada in 1999. It is currently approved for the treatment of acute and chronic symptoms of osteoarthritis, rheumatoid arthritis, acute pain and menstrual pain.

In 2002, Health Canada issued an advisory, which included preliminary information about increased risk of cardiovascular events related to the use of Vioxx®. The advisory was prompted by the results of a 2000 study entitled VIGOR (Vioxx® Gastrointestinal Outcomes Research). Subsequently, Health Canada implemented labelling changes to reflect the findings from the VIGOR study, specifically the inclusion of information that Vioxx® should be used with caution in patients with a history of heart disease. Since then, Health Canada has been actively monitoring all COX-2 selective NSAIDs for gastrointestinal and cardiovascular events.

Health Canada recommends consumers return the product to their pharmacy. Consumers should not flush unused drugs down the toilet or sink to avoid contaminating ground or municipal water systems.

Health Canada has been in contact with Merck & Co and will be monitoring the removal of this product from the Canadian market.

Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988

Public Inquiries:
(613) 957-2991
http://www.hc-sc.gc.ca

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