Advisory

2002-29
April 19, 2002

Important safety information for patients taking VIOXX® (rofecoxib)

OTTAWA - Health Canada is advising Canadians of safety information related to the selective COX-2 inhibitor VIOXX® (rofecoxib), which is a nonsteroidal anti-inflammatory drug (NSAID). VIOXX® is a prescription drug in Canada approved for use in the treatment of osteoarthritis, menstrual pain and acute pain in adults.

Results from a large post-market clinical trial "Vioxx Gastrointestinal Outcomes Research (VIGOR)" have shown that a risk of gastrointestinal toxicity associated with the use of VIOXX® exists, although it is less than half that of another NSAID drug, naproxen. Patients taking VIOXX®, especially the elderly, are advised that in rare cases, serious stomach problems such as bleeding can occur. Patients who experience symptoms of gastrointestinal toxicity such as gastric pain and blood in stools while on VIOXX® therapy should inform their physician immediately.

Results from the same study have also shown a higher rate of cardiovascular adverse events in the VIOXX® group. Although a relationship between these cardiovascular findings and the use of VIOXX® has not been established at this time, Health Canada, as a precaution, is advising patients with a medical history of hypertension (high blood pressure), ischemic heart disease (angina, heart attack), fluid retention (swelling of the legs), or heart failure to discuss their medical condition with their physician before taking VIOXX®. Patients who develop fluid retention or swelling, shortness of breath, weakness, fatigue, excessive weight gain or chest pain while on VIOXX® therapy should inform their physician immediately.

As with all NSAID drugs, VIOXX® should not be used in patients with a history of:

• Active peptic ulcer, active gastric bleeding, active inflammatory disease of the bowel;
• Active liver diseases;
• Severe kidney problems.

Patients taking other NSAID drugs, including other selective COX-2 inhibitors, are advised to inform their physician if they experience any of the above adverse events.

This advisory is in addition to a letter issued by the manufacturer of VIOXX®, following discussions with Health Canada, to health professionals reminding them of the above-mentioned safety information.

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Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189

Public Inquiries:
(613) 957-2991