Nabumetone is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), and is primarily used to treat pain, inflammation and stiffness caused by arthritis.
Relafen works by reducing the level of hormones in the body that can cause pain and inflammation. In addition to the warnings provided with the packaging of the medication and those related by a physician, there are other important concerns that users of Relafen should know about.
A severe adverse reaction called Stevens-Johnson Syndrome has been linked to use of the drug Relafen.
The symptoms of Stevens-Johnson Syndrome can begin as some form of upper respiratory infection, including also fever, sore throat, inflammation of the mouth, chills, headaches, aching of the joints, and generally feeling ill. After onset, Stevens-Johnson Syndrome will continue to develop, affecting the various mucous membranes of the body, including the mouth, esophagus, nostrils, eyes, genitals, and anal regions. Lesions may develop and the skin may blister or even detach in severe cases.
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.
Medline Plus, 2006People who take nonsteroidal anti-inflammatory medications (NSAIDs) (other than aspirin) such as nabumetone may have a higher risk of having a heart attack or a stroke than people who do not take these medications.
FDA label Reflafen, Oct 2000 Relafen (nabumetone) is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone.
Jonca C. Bull, M.D., 2000 Please refer to your supplemental new drug application dated October 27, 2000, received October 30, 2000, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Relafen nabumetone) Tablets.