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Relafen
Manufacturer: Glaxo
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, 2006
Ashworth NL, J Rheumatol. 2005 Nov;32(11):2212-7. PMID: 16265705 [PubMed - in process]
Canudas N, Pharmazie. 2005 Aug;60(8):604-8. PMID: 16124404 Cyclo-oxygenase 2 inhibitor, nabumetone, inhibits proliferation in chronic myeloid leukemia cell lines.
Vural F, Leuk Lymphoma. 2005 May;46(5):753-6. PMID: 16019514 Photosensitizing properties of 6-methoxy-2-naphthylacetic acid, the major metabolite of the phototoxic non-steroidal anti-inflammatory and analgesic drug nabumetone.
Am J Health Syst Pharm. 2005 Apr 1;62(7):739-43 Patient characteristics associated with outpatient prescriptions for nabumetone and oxaprozin versus celecoxib and rofecoxib.
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Brinker A, Am J Health Syst Pharm. 2005 Apr 1;62(7):739-43. PMID: 15790802 Patient characteristics associated with outpatient prescriptions for nabumetone and oxaprozin versus celecoxib and rofecoxib. |
Hedner T, Drugs. 2004;64(20):2315-43; PMID: 15456329 Nabumetone: therapeutic use and safety profile in the management of osteoarthritis and rheumatoid arthritis.
Ashworth NL, J Rheumatol. 2004 May;31(5):951-6. PMID: 15124256 A population based historical cohort study of the mortality associated with nabumetone, Arthrotec, diclofenac, and naproxen.
Eon Labs Manufacturing, Inc. ...ANDA 75-280 February 25, 2002 The listed drug product referenced in your application (RLD), Relafen Tablets, 500 mg and 750 mg, of SmithKline Beecham Pharmaceuticals, is
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.
Warning Letters and Untitled Letters to Pharmaceutical, 1998 ...... Relafen (nabumetone) Tablets, SmithKline Beecham Pharm. DDMAC, 3/13, 3/18. Selegiline Tablets, Lederle Laboratories, DDMAC, 3/18, 4/3. ...Document is from: CDER
Warning Letters and Notice of Violation Letters to, 1997...... Relafen (nabumetone) tablets, SmithKline Beecham Pharmaceuticals, DDMAC, 1/23/97. Site inspection,
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