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Medical Forum / Diseases and Disorders / Arthritis / August 2006

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Relafen

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Califchief - 26 Aug 2006 20:41 GMT
Betty wrote:

> Looking for personal comments on Relafen.
> Seems to have very serious side effects.

Relafen Side Effects, and Drug Interactions - Nabumetone - RxList Monographs

Nabumetone

     SIDE EFFECTS
     Adverse reaction information was derived from blinded-controlled and
     open-labelled clinical trials and from worldwide marketing experience. In
     the description below, rates of the more common events (greater than 1%)
     and many of the less common events (less than 1%) represent results of US
     clinical studies.

     Of the 1,677 patients who received RELAFEN during US clinical trials,
     1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929
     for at least a year, and 750 for at least 2 years. More than 300 patients
     have been treated for 5 years or longer.
     The most frequently reported adverse reactions were related to the
     gastrointestinal tract and included diarrhea, dyspepsia, and abdominal
     pain.
     Incidence ³1% Probably Causally Related

     Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%),
     constipation*, flatulence*, nausea*, positive stool guaiac*, dry mouth,
     gastritis, stomatitis, vomiting.

     Central Nervous System: Dizziness*, headache*, fatigue, increased
     sweating, insomnia, nervousness, somnolence.

     Dermatologic: Pruritus*, rash*.

     Special Senses: Tinnitus*.

     Miscellaneous: Edema*.
     *Incidence of reported reaction between 3% and 9%. Reactions occurring in
     1% to 3% of the patients are unmarked.
     Incidence <1% Probably Causally Related†
     Gastrointestinal: Anorexia, jaundice, duodenal ulcer, dysphagia, gastric
     ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite,
     liver function abnormalities, melena, hepatic failure.

     Central Nervous System: Asthenia, agitation, anxiety, confusion,
     depression, malaise, paresthesia, tremor, vertigo.

     Dermatologic: Bullous eruptions, photosensitivity, urticaria,
     pseudoporphyria cutanea tarda, toxic epidermal necrolysis, erythema
     multiforme, Stevens-Johnson syndrome.

     Cardiovascular: Vasculitis.

     Metabolic: Weight gain.

     Respiratory: Dyspnea, eosinophilic pneumonia, hypersensitivity
     pneumonitis, idiopathic interstitial pneumonitis.

     Genitourinary: Albuminuria, azotemia, hyperuricemia, interstitial
     nephritis, nephrotic syndrome, vaginal bleeding, renal failure.

     Special Senses: Abnormal vision.

     Hematologic/Lymphatic: Thrombocytopenia.

     Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioneurotic
     edema.

     Adverse reactions reported only in worldwide postmarketing experience or
     in the literature, not seen in clinical trials, are considered rarer and
     are italicized.
     Incidence <1% Causal Relationship Unknown

     Gastrointestinal: Bilirubinuria, duodenitis, eructation, gallstones,
     gingivitis, glossitis, pancreatitis, rectal bleeding.

     Central Nervous System: Nightmares.

     Dermatologic: Acne, alopecia.

     Cardiovascular: Angina, arrhythmia, hypertension, myocardial infarction,
     palpitations, syncope, thrombophlebitis.

     Respiratory: Asthma, cough.

     Genitourinary: Dysuria, hematuria, impotence, renal stones.

     Special Senses: Taste disorder.

     Body as a Whole: Fever, chills.

     Hematologic/Lymphatic: Anemia, leukopenia, granulocytopenia.

     Metabolic/Nutritional: Hyperglycemia, hypokalemia, weight loss.

     DRUG INTERACTIONS

     ACE-inhibitors: Reports suggest that NSAIDs may diminish the
     antihypertensive effect of ACE-inhibitors. This interaction should be
     given consideration in patients taking NSAIDs concomitantly with
     ACE-inhibitors.

     Aspirin: When RELAFEN is administered with aspirin, its protein binding is
     reduced, although the clearance of free RELAFEN is not altered. The
     clinical significance of this interaction is not known; however, as with
     other NSAIDs, concomitant administration of nabumetone and aspirin is not
     generally recommended because of the potential of increased adverse
     effects.

     Diuretics: Clinical studies, as well as post marketing observations, have
     shown that RELAFEN can reduce the natriuretic effect of furosemide and
     thiazides in some patients. This response has been attributed to
     inhibition of renal prostaglandin synthesis. During concomitant therapy
     with NSAIDs, the patient should be observed closely for signs of renal
     failure (see PRECAUTIONS, Renal Effects), as well as to assure diuretic
     efficacy.

     Lithium: NSAIDs have produced an elevation of plasma lithium levels and a
     reduction in renal lithium clearance. The mean minimum lithium
     concentration increased 15% and the renal clearance was decreased by
     approximately 20%. These effects have been attributed to inhibition of
     renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium
     are administered concurrently, subjects should be observed carefully for
     signs of lithium toxicity.

     Methotrexate: NSAIDs have been reported to competitively inhibit
     methotrexate accumulation in rabbit kidney slices. This may indicate that
     they could enhance the toxicity of methotrexate. Caution should be used
     when NSAIDs are administered concomitantly with methotrexate.
     Warfarin: The effects of warfarin and NSAIDs on GI bleeding are
     synergistic, such that users of both drugs together have a risk of serious
     GI bleeding higher than users of either drug alone.
     In vitro studies have shown that, because of its affinity for protein,
     6MNA may displace other protein-bound drugs from their binding site.
     Caution should be exercised when administering RELAFEN with warfarin since
     interactions have been seen with other NSAIDs.
     Concomitant administration of an aluminum-containing antacid had no
     significant effect on the bioavailability of 6MNA. When administered with
     food or milk, there is more rapid absorption; however, the total amount of
     6MNA in the plasma is unchanged (see CLINICAL PHARMACOLOGY,
     Pharmacokinetics).

... Some people (like Tom) are like a Slinky...not really
... good for anything, but you still can't help but smile
... when you see one tumble down the stairs.
in4pharm@yahoo.com - 27 Aug 2006 22:37 GMT
> Betty wrote:
>
[quoted text clipped - 141 lines]
> ... good for anything, but you still can't help but smile
> ... when you see one tumble down the stairs.

Some more info about classes and pharmacotherapeutical treatment of
anaemia (anemia) and related medical conditions:
http://drugs-about.com/icd/d50-d53.html - Nutritional Anaemias -
Drugs-about.com - ICD-10
in4pharm@yahoo.com - 28 Aug 2006 17:15 GMT
More info about classes and pharmacotherapeutical treatment of
hypertension and related medical conditions of high blood pressure:
http://drugs-about.com/icd/i10-i15.html - Hypertension Diseases -
Drugs-about.com - ICD-10
 
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