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Use of rofecoxib at 50 mg for more than 5 days for osteoarthritis should be discouraged due to dose-related problems

Rofecoxib (Vioxx®) is a nonsteroidal antiinflammatory drug (NSAID) licensed for chronic use for osteoarthritis at doses of 12.5 mg and 25 mg. A 50 mg dose is recommended for acute pain for a maximum of 5 days. Nevertheless, use of rofecoxib at 50 mg for more than 5 days is relatively common, according to a recent study by researchers at the Vanderbilt University Center for Education and Research on Therapeutics (CERTs). The study was supported by the Agency for Healthcare Research and Quality through the CERTs program (HS10384).

Despite the relative gastrointestinal safety of rofecoxib, even at the 50 mg dose, drug-related hypertension and edema are relatively common. Since the 50 mg dose has not been shown to be more effective than lower doses, chronic use of high-dose rofecoxib should be discouraged, according to Marie R. Griffin, M.D., M.P.H., of the Vanderbilt CERTs.

Dr. Griffin and her colleagues analyzed the prevalence of chronic use of rofecoxib at 50 mg in 2001 among people aged 50 years and older who were enrolled in the Tennessee Medicaid program. On July 1, 2001, 14 percent of the group had a current prescription for an NSAID, with a supply of pills for more than 5 days. Of all NSAID prescriptions, 25 percent were for rofecoxib, and 17 percent of these prescriptions were for more than 25 mg daily.

Of those prescribed more than 25 mg daily, 71 percent filled prescriptions for at least 50 mg for 30 days. In this latter group, 60 percent filled another rofecoxib prescription within 1 week and 69 percent within 2 weeks at the end of their 30-day supply, suggesting that the 50 mg dose was indeed being used close to daily.

See "High frequency of use of rofecoxib at greater than recommended doses: Cause for concern," by Dr. Griffin, C. Michael Stein, M.D., David J. Graham, M.D., and others, in Pharmacoepidemiology and Drug Safety 13, p. 339-343, 2004.

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