"The US Food and Drug Administration's (FDA's) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted yesterday to recommend premarket approval of the Cartiva Synthetic Cartilage Implant for use in pati"...
(Generic versions may still be available.)
BEXTRA (valdecoxib) can cause GI discomfort and, rarely, more serious GI side effects, 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 sign or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS - Gastrointestinal (GI) Effects Risk - of GI Ulceration, Bleeding, and Perforation).
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 attention.
Patients should also be instructed to seek immediate emergency help in the case of an anaphylactoid reaction (see WARNINGS - Anaphylactoid Reactions).
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Bextra Information
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