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FDA Panel Recommends Vioxx For Acute Pain, Osteoarthritis MONTREAL, QC -- April 20, 1999 -- Reuters reports that an advisory panel to the United States Food and Drug Administration has voted to approve Merck’s Vioxx(TM) (rofecoxib) for the treatment of osteoarthritis and for acute pain, such as menstrual pain and post-surgical pain. This recommendation follows Health Canada’s decision to grant fast-track review status to the drug for the osteoarthritis indication. Clinical studies to date demonstrate that Vioxx is as effective in relieving pain and inflammation as the maximum doses of non-steroidal anti-inflammatory drugs (NSAIDs), without the gastrointestinal side effects. NSAIDs such as aspirin, diclofenac and ibuprofen are currently the most common medications used to relieve pain and inflammation due to arthritis. However, they can lead to serious GI side effects. Peptic ulcers, which may result in bleeding and/or perforation, are among the more serious complications. There are two types of cyclooxygenase in the body. Cyclooxigenase-I (COX-I) produces prostaglandins that are believed to be responsible, among other things, for the protection of the stomach lining. Cyclooxygenase-II (COX-II) produces prostaglandins believed to be responsible for pain and inflammation. NSAIDs act by inhibiting both COX-II and COX-I which can cause serious gastrointestinal side effects such as ulcers, stomach perforations and bleeds. COX-II specific inhibitors work by inhibiting the role of COX-II on pain and inflammation without inhibiting COX-I which protects gastrointestinal lining. As a COX-II specific inhibitor, rofecoxib's once daily dosing is expected to enhance compliance among patients with osteoarthritis while improving their quality of life. Osteoarthritis is the most common form of arthritis affecting one in 10 Canadians. Osteoarthritis is a degenerative joint disease characterised by the deterioration of joint cartilage and adjacent bones. E-mail this page to a friend or colleague! To print, use this version