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| |  FDA Approves Vioxx For Osteoarthritis, Acute Pain In Adults And Menstrual Pain WEST POINT, PA -- May 21, 1999 - The United States Food and Drug Administration has approved Merck & Co., Inc.’s once-a-day medicine Vioxx(R) (rofecoxib) for relief of the signs and symptoms of osteoarthritis (OA), management of acute pain in adults and treatment of menstrual pain (primary dysmenorrhea). Vioxx was evaluated for the treatment of the signs and symptoms of OA in placebo- and active-controlled clinical trials of six to 86 weeks that included approximately 3,900 patients. The effectiveness of Vioxx 12.5 mg and 25 mg once a day was shown to be comparable to prescription-strength non-steroidal, anti-inflammatory drugs (NSAIDs) ibuprofen 800 mg three times a day and diclofenac 50 mg three times a day for treatment of the signs and symptoms of OA. The ibuprofen studies were six-week studies; the diclofenac studies were 12-month studies in which patients could receive additional arthritis medication during the last six months. In all OA clinical studies, once-daily treatment in the morning with Vioxx 12.5 mg and 25 mg was associated with a significant reduction in joint stiffness upon first awakening in the morning. Furthermore, in two six-month studies of OA patients, treatment with Vioxx 25 mg daily or 50 mg daily was associated with a significantly lower percentage of patients with gastroduodenal ulcers, as detected by an endoscope, than treatment with ibuprofen 2,400 mg daily. An endoscope is an instrument designed to look inside the stomach. The correlation between findings of endoscopic studies and the relative incidence of clinically serious upper gastrointestinal (GI) events that may be observed with different products, has not been fully established. Serious clinically significant upper GI bleeding has been observed in patients receiving Vioxx in controlled trials, albeit infrequently. Prospective, long-term studies required to compare the incidence of serious, clinically significant upper GI adverse events in patients taking Vioxx versus comparator NSAID products have not been performed. In studies of post-operative dental pain, post-orthopaedic surgical pain and primary dysmenorrhea, Vioxx relieved pain that was rated by patients as moderate to severe. Studies lasted up to five days. The analgesic effect (including onset of action) of a single 50 mg dose of Vioxx was generally similar to naproxen sodium 550 mg or ibuprofen 400 mg. The most common side effects reported in clinical trials with Vioxx were upper-respiratory infection, diarrhea and nausea. People who have had an allergic reaction to Vioxx, aspirin or other traditional NSAIDs should not take Vioxx. Although Vioxx has a low potential for stomach ulcers, serious GI ulcers can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of GI bleeding. Vioxx should not be taken by women in late pregnancy. Safety and effectiveness in children have not been evaluated. The recommended dose for OA is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. For acute pain, the recommended dose is Vioxx 50 mg once daily. Use of Vioxx for more than five days for the management of pain has not been studied. At recommended doses, scientists believe Vioxx blocks the enzyme that triggers pain and inflammation (COX-2), while sparing a related enzyme that helps maintain the normal stomach lining (COX-1). In general, traditional NSAIDs block both enzymes. They treat pain and inflammation, but may damage the stomach lining, potentially leading to ulcers in some patients. Osteoarthritis is the most common form of arthritis and a leading cause of disability and nursing home admission in the U.S. It is a progressive, degenerative joint disease in which the cartilage covering the ends of the bones deteriorates, causing varying degrees of pain, inflammation and disability. Related Links: Merck & Co. Inc..
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