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Pharmacoepidemiol Drug Saf. 2004 Jun;13(6):339-43.

High frequency of use of rofecoxib at greater than recommended doses: cause for concern.

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Department of Preventive Medicine, Vanderbilt University Medical Center, Nashville, TN 37232, USA.



To determine the prevalence of chronic use of rofecoxib 50 mg. Rofecoxib is unusual among nonsteroidal anti-inflammatory drugs (NSAIDs) in that the licensed dose for acute pain is double the maximum dose recommended for chronic use. The 50 mg dose is recommended for acute pain only, for a maximum of 5 days. In clinical trials of chronic use for arthritis, hypertension was more frequent in patients assigned 50 mg rofecoxib than in those assigned lower doses or other NSAIDs. Thus chronic use of high doses of rofecoxib has implications for patient safety.


Cross-sectional analysis of the prevalence of chronic use of rofecoxib 50 mg in 2001, among persons aged > or =50 years, enrolled in the Tennessee Medicaid program.


On 1 July 2001, 14% of the study population had a current prescription for an NSAID, with a supply of pills for >5 days. Of all NSAID prescriptions, 25% were for rofecoxib, and 17% of these prescriptions were for >25 mg daily. Of those prescribed >25 mg daily, 71% filled prescriptions for at least 50 mg for 30 days. In this latter group, 60% and 69% filled another rofecoxib prescription within 1 and 2 weeks, respectively, of the end of their 30 days supply. Demographics and co-morbid conditions of high dose rofecoxib users did not differ substantially from users of other NSAIDs or the total population.


Use of rofecoxib 50 mg for >5 days is relatively common. In view of dose-related adverse effects, such use should be discouraged.

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