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For Immediate Release, December 22,
2004 - Corrected
Arthritis News
AMERICAN COLLEGE OF RHEUMATOLOGY OFFERS
GUIDANCE FOR ASSESSING ARTHRITIS PAIN MEDICATION
USAGE
ATLANTA, GEORGIA – For patients with arthritis and the physicians
who treat them, “it remains critical to consider factors that
affect the risk/benefit ratio when determining whether to continue
or discontinue any pharmaceutical product, including those NSAIDs
(non-steroidal anti-inflammatory drugs) that are under scrutiny
for potential increased health risks,” stated American College
of Rheumatology president, Elizabeth Tindall, MD. “Treatment
guidelines exist to help physicians choose the best treatment
options for their patients based on current scientific studies.”
In September 2004 Merck voluntarily removed rofecoxib (Vioxx®)
from the world market due to adverse cardiovascular and cerebrovascular
events. Since then, multiple reports of other NSAIDs possibly
causing these same adverse effects have been released to the
press. Many patients and physicians are disconcerted by the conflicting
preliminary data regarding potential risks from taking celecoxib
(Celebrex®), valdecoxib (Bextra®) and most recently naproxen
(Aleve®).
The newest data reported by Pfizer from the APC and PreSAP studies
suggest the possibility of increased risk of serious cardiovascular
events for patients taking Celebrex® at doses of 400 mg to
800 mg daily. Information reported in November 2004 suggested
that Bextra® posed similar risks for cardiovascular events
as that of Vioxx®. In another trial, Aleve®, a drug previously
believed to have some preventive cardiovascular effects, also
showed indications of elevating heart risks and strokes in a
study designed to prevent Alzheimer's disease. In each case,
the FDA is analyzing the data and has offered limited warnings.
In the case of Aleve®, the FDA recommends that patients take
it for no more than ten days and then contact their physicians
for further recommendations. The FDA has asked Pfizer to voluntarily
discontinue all direct-to-consumer advertising for Celebrex® and
has required strengthened label warnings for Bextra®.
“It is unfortunate that physicians and patients have limited
preliminary data, some of it in direct conflict with existing
conclusions, causing anxiety that, at this time, cannot be definitively
confirmed nor refuted,” stated Dr. Tindall. Because peer-reviewed
data and analysis are not available to substantiate the studies'
preliminary results, the validity of elevated health risk conclusions
are unknown. To address these concerns, the American College
of Rheumatology advises physicians to follow the current treatment
guidelines and manufacturers' dosage recommendations.
Treatment guidelines developed by the American College of Rheumatology
for rheumatoid arthritis 1 (RA) in 2002 and osteoarthritis 2
(OA) in 2000 include recommendations for patients at high risk
for adverse gastrointestinal (GI) events. These guidelines are
consistent with existing, documented peer-reviewed study data.
Patients taking Celebrex®, Bextra® and Aleve® who
have concerns about their risks for GI or cardiovascular complications
should consider stopping the medication or substituting another
pain medication when medically appropriate and in coordination
with their physicians' advice. Definitive recommendations regarding
the risk profile of medications that modify pain and inflammation
will continue to evolve. Complete analysis of data from existing,
current and future studies specifically designed to test cardiovascular
effects of these agents will be incorporated in updated guidelines.
The American College of Rheumatology is the professional organization
for rheumatologists and health professionals who share a dedication
to healing, preventing disability and curing arthritis and related
rheumatic and musculoskeletal diseases.
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1 Kwoh, et al, Guidelines for the Management of Rheumatoid Arthritis – 2002
Update. Arthritis Rheum 2002; 328-346.
2 Altman, et al, Recommendations for the Medical Management
of Ostoearthritis of the Hip and Knee. Arthritis Rheum 2000;
1905-1915.