(Sulindac)
Manufacturer: Merck
Sulindac is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), and is primarily used to reduce pain, inflammation, and stiffness caused by many conditions, such as osteoarthritis and rheumatoid arthritis. It is also used to treat bursitis, tendinitis, acute gouty arthritis, and other types of pain.
Drugs@FDA, 2006 This supplemental new drug application provides for revisions to the CLINICAL PHARMACOLOGY section of the package insert. Basic Clin Pharmacol Toxicol. 2006 Oct;99(4):294-9
Mitochondrial uncoupling by the sulindac metabolite, sulindac sulfide.
Clin Ther. 2006 Aug;28(8):1123-32.
Hepatic disorders in patients treated with COX-2 selective inhibitors or nonselective NSAIDs: a case/noncase analysis of spontaneous reports.
Life Sci. 2006, Nov 10;79(24):2269-74. Epub 2006 Aug 1.Non-steroidal anti-inflammatory agents, tolmetin and sulindac, inhibit liver tryptophan 2,3-dioxygenase activity and alter brain neurotransmitter levels.
Fundam Clin Pharmacol, 2006 Aug;20(4):391-5 Non-steroidal anti-inflammatory drug-related hepatic damage in France and Spain: analysis from national spontaneous reporting systems.
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FDA NSAIDs Decision Memo
SUBJECT: Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk
Executive Summary
Following a thorough review of the available data we have reached the following conclusions regarding currently approved COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs)1 and the risk of adverse cardiovascular (CV) events:2
• The three approved COX-2 selective NSAIDs (i.e., celecoxib, rofecoxib, and valdecoxib) are associated with an increased risk of serious adverse CV events compared to placebo. The available data do not permit a rank ordering of these drugs with regard to CV risk.
• Data from large long-term controlled clinical trials that have included a comparison of COX-2 selective and non-selective NSAIDs do not clearly demonstrate that the COX-2 selective agents confer a greater risk of serious adverse CV events than non-selective NSAIDs.
