High frequency of use of rofecoxib at greater than recommended doses: cause for concern
Article first published online: 15 JUL 2003
Copyright © 2003 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 13, Issue 6, pages 339–343, June 2004
How to Cite
Griffin, M. R., Stein, C. M., Graham, D. J., Daugherty, J. R., Arbogast, P. G. and Ray, W. A. (2004), High frequency of use of rofecoxib at greater than recommended doses: cause for concern. Pharmacoepidem. Drug Safe., 13: 339–343. doi: 10.1002/pds.879
- Issue published online: 19 MAY 2004
- Article first published online: 15 JUL 2003
- Manuscript Accepted: 9 MAY 2003
- Manuscript Revised: 28 APR 2003
- Manuscript Received: 14 NOV 2002
- Agency for Healthcare Research and Quality (AHRQ). Grant Number: U18 HS 10384
- nonsteroidal anti-inflammatory drugs;
- Cox-2 inhibitors;
- drug safety;
- drug utilization
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 ≥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. Copyright © 2003 John Wiley & Sons, Ltd.