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Cardiovascular Risk
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at a greater risk. (See WARNINGS).
- RELAFEN is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
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RELAFEN SUMMARY
RELAFEN®
(nabumetone)
Tablets
Relafen is a nonsteroidal anti-inflammatory drug (NSAID).
Relafen
is indicated for acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis.
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NEWS HIGHLIGHTS
Published Studies Related to Relafen (Nabumetone)
High-throughput LC-MS/MS assay for 6-methoxy-2-naphthylacetic acid, an active metabolite of nabumetone in human plasma and its application to bioequivalence study. [2008.11]
A simple, precise and accurate assay for the determination of 6-methoxy-2-naphthylacetic acid (6-MNA), an active metabolite of nabumetone in human plasma, was developed and validated using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The analyte (6-MNA) and propranolol (internal standard, IS) were extracted from 200 microL aliquot of human plasma via solid-phase extraction employing HLB Oasis cartridges and separated on a Discovery HS C18 (50 x 4.6 mm, 5 microm) column...
Treatment of patients with osteoarthritis with rofecoxib compared with nabumetone. [2006.02]
BACKGROUND: Rofecoxib and nabumetone were developed to provide gastrointestinal benefits over traditional nonsteroidal antiinflammatory drugs (NSAIDs). However, there is limited comparative information relating to these 2 drugs. OBJECTIVE: The objective of this study was to compare rofecoxib and nabumetone, at their lower, recommended doses, in patients with osteoarthritis (OA)... CONCLUSIONS: At their recommended starting doses for OA, both agents were more effective than placebo. Rofecoxib at a dosage of 12.5 mg demonstrated significantly better efficacy in PGART than 1000 mg nabumetone in these patients known to be NSAID responders. Significantly more AEs occurred with rofecoxib than nabumetone. Considering these data and other recent safety information regarding cyclooxygenase-2 selective and nonselective NSAIDS, physicians must make risk/benefit assessments for each individual patient when considering the use of these agents, as recommended by the U.S. Food and Drug Administration.
Pulp-dentine complex changes and root resorption during intrusive orthodontic tooth movement in patients prescribed nabumetone. [2005.01]
Pulpitis, external root resorption, and pain may be experienced during orthodontic movement... Nabumetone was found to be useful in reducing pulpitis, external root resorption, and pain caused by intrusive orthodontic movement, without altering tooth movement in response to the application of orthodontic force.
Pain management in osteoarthritis: a focus on onset of efficacy--a comparison of rofecoxib, celecoxib, acetaminophen, and nabumetone across four clinical trials. [2004.11]
We compared onset of efficacy (during days 1 to 6) of 2 coxibs (rofecoxib, celecoxib) with acetaminophen and nabumetone by using a prespecified approach to data from 4 similarly designed 6-week randomized osteoarthritis trials. In 2 trials, rofecoxib (12.5 mg and 25 mg once daily) was compared with celecoxib (200 mg once daily) and acetaminophen (4000 mg daily).
Efficacy and safety of rofecoxib 12.5 mg versus nabumetone 1,000 mg in patients with osteoarthritis of the knee: a randomized controlled trial. [2004.05]
OBJECTIVES: To evaluate the use of starting doses of rofecoxib and nabumetone in patients with osteoarthritis (OA) of the knee... CONCLUSION: Rofecoxib 12.5 mg daily demonstrated better efficacy over 6 weeks of treatment and quicker onset of OA efficacy over the first 6 days than nabumetone 1,000 mg daily. Both therapies were generally well tolerated.
Clinical Trials Related to Relafen (Nabumetone)
Functional MRI (fMRI) in CGRP Induced Migraine [Not yet recruiting]
In patients known with migraine without aura a migraine headache or migraine like headache
will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then
be stimulated with noxious heat via a thermode placed at the forehead. At the same time the
Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic
ressonanse imaging (fMRI), to estimate the central-nervous pain response. The regions of
interest (ROI) will be thalamic region and medulla oblongata.
Then the patients will be given pain relif in form of injection of sumatriptan and the effect
of this will also be registered via measuring the BOLD response at the RIO's previously
defined. A 3-Tesla MRI scanner will be used in this trail.
This study will give us key knowledge of the trigeminal pain pathway and the central
processing i. e sensitization during a migraine attach.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Relafen has an overall score of 5. The effectiveness score is 4 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Relafen review by 40 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | sciatica |
| Dosage & duration: | | 750mg taken 2 pills once daily for the period of 6 months |
| Other conditions: | | na |
| Other drugs taken: | | glipizide | | |
Reported Results |
| Benefits: | | The only benefit I received from this drug was the ability to get through my day without experiencing unbearable pain. My sciatica was not a condition that flared up continually; rather, it came approximately 4-6 times per month. |
| Side effects: | | Excessive sleepiness, lack of concentration, feelings similar to those that one would experience taking oxycodone. I felt "high" for many hours after taking this drug. |
| Comments: | | The plan was a permanent solution to my occasional flare-ups of sciatica. My physician basically stated that there was no cure for my pain; therefore, I needed to be placed on a prescription regimen that would hopefully reduce the occurrence and/or frequency of sciatica. Each bottle contained a 60 day supply with enough refills to last me an entire year. I have 2 herniated discs, one at L4-L5 and the other at S1. The herniation at L4-L5 was causing pressure on my sciatic nerve which runs down the length of the left leg. For me, this drug was not effective; perhaps, if I had continual pain I would learn to live with the side-effects. I did stop taking any medications for my condition and am learning to cope without prescriptions at this time. It appears that eventually I will need to take medication but I want to avoid feeling "doped up" for as long as possible. |
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Page last updated: 2009-02-08
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