The patient's perspective on the recall of Vioxx.
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).


CONCLUSIONS
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.
Hawker
Gillian A
GA
Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. gillian.hawker@sw.ca
Katz
Jeffrey N
JN
Solomon
Daniel H
DH
D000368:Aged; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000503:physiopathology; D003142:Communication; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects*; D004335:Drug and Narcotic Control; D005260:Female; D006801:Humans; D007783:Lactones / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000188:drug therapy; D020370:Osteoarthritis, Knee / Q000188:drug therapy; D010353:Patient Education as Topic; D010361:Patients / Q000523:psychology*; D011639:Public Opinion; D013450:Sulfones / Q000009:adverse effects*
D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib