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The Patient's Perspective on the Recall of Vioxx
GILLIAN A. HAWKER, JEFFREY N. KATZ, and DANIEL H. SOLOMON ABSTRACT. Objective. Rofecoxib was recalled in September 2004 when studies identified increased cardiovascular risk compared with placebo among patients taking rofecoxib. We examined the reactions of people with arthritis to this recall. Methods. Telephone interviews were conducted between December 2004 and February 2005 in a previously assembled community based cohort (n = 1085) with disabling hip/knee osteoarthritis (OA) residing in 2 regions of Ontario, Canada (one urban, one rural). Respondents' self-reported experience with cyclooxygenase (COX-2) selective nonsteroidal antiinflammatory drugs (NSAID; coxibs), issues around communication of the recall, attitudes about pain medications, and understanding of the rofecoxib-associated cardiovascular risks were assessed. Participants were also asked about contraindications for traditional NSAID use (specific clinical conditions, use of blood thinners and glucocorticoids, and history of gastrointestinal (GI) ulcer and/or bleeding). Results. The response rate was 93.5%; 968 completed the survey. Half (53.0%) had used a coxib for arthritis; 277 (28.6%) had used rofecoxib. Only 3.8% of "ever" coxib users reported previous GI ulcer or hemorrhage. 94.8% of respondents had heard about the recall; most (94.7%) had heard via television. Among the 83 individuals taking rofecoxib at recall, 90.4% had been offered another pain medication, mainly another coxib. Most of the 968 participants (> 60%) were unfamiliar with rofecoxib-associated cardiovascular risks. Of those with an opinion, most overestimated the absolute risk associated with rofecoxib (55.7% cited a risk > 5 events/100 people/year). Conclusion. In an elderly community cohort with OA, the prevalence of coxib use was high despite few major contraindications to NSAID. Many were unaware of or overestimated the absolute risks associated with rofecoxib use, highlighting the need for strategies by which physicians/pharmacists can provide their patients with timely and accurate drug safety information. (J Rheumatol 2006;33:1082–8) Key Indexing Terms:
ROFECOXIB
From the Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Section of Clinical Sciences, Division of Rheumatology, Immunology and Allergy; and Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massuchusetts, USA. Supported by a grant from the Canadian Institutes of Health Research. Dr. Hawker receives salary support as the F.M. Hill Chair in Academic Women's Medicine at Sunnybrook and Women's College Health Sciences Centre and the University of Toronto. Dr. Katz is supported by National Institutes of Health (NIH) grants K24 AR 021213 and P60 AR 47782, the Arthritis Foundation, the New England Baptist Hospital, and a research grant from Novartis. Dr. Solomon has received research support from Merck and Pfizer as well as the NIH (K23 AR48616, R01 DA15507), the Arthritis Foundation, and the Engalitcheff Arthritis Outcomes Initiative. G.A. Hawker, MD, MSc, FRCPC, Department of Health Policy, Management and Evaluation, University of Toronto, Institute for Clinical Evaluative Sciences, and Division of Rheumatology, Department of Medicine, Sunnybrook and Women's College Health Sciences Centre and the University of Toronto; J.N. Katz, MD, MSc, Section of Clinical Sciences, Division of Rheumatology, Immunology and Allergy, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School; D.H. Solomon, MD, MPH, Section of Clinical Sciences, Division of Rheumatology, Immunology and Allergy, Division of Pharmacoepidemiology, Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School. Address reprint requests to Dr. G.A. Hawker, Sunnybrook and Women's College Health Sciences Centre, 76 Grenville Street, Room 815, Toronto, Ontario M5S 1B2. E-mail: gillian.hawker@sw.ca Accepted for publication January 12, 2006.
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