E-drug: Renal failure associated with the use of COX-2 inhibitors
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Ahmad S.R.; Kortepeter C.; Brinker A.; Chen M.; Beitz J. Renal Failure
Associated with the Use of Celecoxib and Rofecoxib. Drug Safety, 2002,
vol. 25, no. 7, pp. 537-544(8)
Abstract:
Objective: Celecoxib and rofecoxib are two relatively new nonsteroidal
anti-inflammatory drugs (NSAIDs) that selectively inhibit the
cyclo-oxygenase-2 (COX-2) isoenzyme at therapeutic concentrations. The
nephrotoxic potential of selective COX-2 inhibitors has not been clearly
established. This study was conducted in order to understand the association
between acute renal failure and the two COX-2 inhibitors celecoxib and
rofecoxib.
Methods: A search was performed in the US Food and Drug Administration's
(FDA) Adverse Event Reporting System (AERS) to identify cases of renal
failure submitted to the FDA. A MEDLINE search of the English language
literature was also performed to identify published cases of renal failure
associated with celecoxib and rofecoxib.
Results: One hundred twenty-two and 142 domestic US cases of celecoxib and
rofecoxib-associated renal failure, respectively, were identified in the
AERS database. The literature search identified 19 cases of acute renal
impairment in association with celecoxib and rofecoxib. In addition, drug
regulatory authorities in the UK, Canada, and Australia have received about
50 reports of renal failure with celecoxib and rofecoxib. Descriptive
statistics of the AERS cases have been summarised in this report.
Conclusions: Data from AERS and published case reports suggest that use of
both these drugs is associated with renal effects similar to that of
conventional nonselective NSAIDs. Physicians should be aware that serious or
life-threatening renal failure has been reported in patients with normal or
impaired renal function after short-term therapy with celecoxib and
rofecoxib. Patients at greatest risk for renal injury are those with
pre-existing renal impairment, heart failure, liver dysfunction, those
taking diuretics and/or ACE inhibitors, and the elderly. Kidney function
should be monitored closely for any signs of potential renal injuries soon
after initiating treatment with these agents, especially in high-risk
populations. In addition, healthcare practitioners should adequately warn
patients of the signs and symptoms of serious renal toxicity, and of the
need for them to see their physician promptly if they occur. Celecoxib and
rofecoxib are not recommended for use in patients with advanced renal
disease.
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