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(Generic versions may still be available.)
Physicians should instruct their patients to read the patient package insert before starting therapy with VIOXX (rofecoxib) and to reread it each time the prescription is renewed in case any information has changed.
VIOXX (rofecoxib) can cause discomfort and, rarely, more serious side effects, such as gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be apprised of the importance of this follow-up. For additional gastrointestinal safety information see CLINICAL STUDIES, Special Studies, VIGOR and WARNINGS, Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding and Perforation. Patients should be informed that VIOXX (rofecoxib) is not a substitute for aspirin for cardiovascular prophylaxis because of its lack of effect on platelets. For additional cardiovascular safety information see CLINICAL STUDIES, Special Studies, VIGOR and PRECAUTIONS, Cardiovascular Effects.
Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
Patients should also be instructed to seek immediate emergency help in the case of an anaphylactoid reaction (see WARNINGS).
Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding.
Last reviewed on RxList: 12/28/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Vioxx Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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