CLINORIL (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.
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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.
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