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| |  Searle & Pfizer Refute Merck's Claims About Benefits Of Vioxx CHICAGO, IL -- June 9, 1999 -- G.D. Searle & Co. and Pfizer Inc. have refuted claims by Merck & Co. about the pain-relieving benefits of Vioxx (rofecoxib), Merck’s COX-2 inhibitor, because conclusions were drawn from a poorly-designed study, they say. Searle and Pfizer, which co-promote Celebrex (celecoxib) said that Merck’s conclusions were erroneous because the company used inequivalent doses when comparing Celebrex to Vioxx. Limited data on the Merck study, a single-dose study in acute dental pain, was made available during a medical meeting in Scotland this week. The study in question compared the lowest recommended dose for Celebrex (200 mg per day) with the highest possible dose of Vioxx (50 mg per day). Searle and Pfizer said they believe these data are misleading because the maximum recommended daily dose of Celebrex in the United States is 400 mg. The 50 mg dose of Vioxx is not approved for use in the United Kingdom, where the data were released. Prescribing information in the U.S. indicates that the 50 mg dose of Vioxx carries a higher incidence of gastrointestinal, renal and cardiovascular side effects compared to the lower 25 mg dose. Further, according to the approved prescribing information in the U.K. patients should not receive more than 25 mg dose of Vioxx per day. "The risks of gastrointestinal symptoms, oedema or hypertension are increased," the prescribing information states. Celebrex is approved in the U.S. for the treatment of the signs and symptoms associated with osteoarthritis and adult rheumatoid arthritis. It is not currently licensed for sale in the European Union.
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