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Health Canada Approves Changes to Vioxx (Rofecoxib) Label to Reflect GI Safety Data from Landmark Study

Merck Frosst Canada Ltd. announced today that Health Canada has approved changes to the prescribing information for Vioxx® (rofecoxib) to include results from the landmark 8,000-patient VIGOR (Vioxx® Gastrointestinal Outcomes Research) study.

Rofecoxib is now the first and only medicine that selectively inhibits the COX-2 enzyme that is proven to reduce the risk of developing clinically important gastrointestinal (GI) side effects in patients with or without risk factors for such GI side effects compared to the non-steroidal anti-inflammatory drug (NSAID) naproxen.

 “It is clear that COX-2 inhibitors offer a significant advantage over other existing therapies such as the use of NSAIDs,” said Dr. Richard Hunt, professor of medicine, McMaster University Medical Centre, Hamilton, Ontario. “NSAIDs are often prescribed to reduce pain and inflammation in patients with arthritis.

However, use of non-selective NSAIDs, especially among older persons, can significantly increase morbidity, including the risk of perforations, ulcers and bleeds which can also result in a measurable mortality.”

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