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Risk of GI Ulceration, Bleeding and Perforation with NSAID Therapy
Serious gastrointestinal toxicity, such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms, in patients treated chronically with NSAID therapy. Although minor upper gastrointestinal problems, such as dyspepsia, are common, usually developing early in therapy, physicians should remain alert for ulceration and bleeding in patients treated chronically with NSAIDs even in the absence of previous GI tract symptoms. In patients observed in clinical trials of several months to two years duration, symptomatic upper GI ulcers, gross bleeding or perforation appear to occur in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur.
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Except for a prior history of serious GI events and other risk factors known to be associated with peptic ulcer disease, such as alcoholism, smoking, etc., no risk factors (e.g., age, sex) have been associated with increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less well than other individuals, and most spontaneous reports of fatal GI events are in this population. Studies to date are inconclusive concerning the relative risk of various NSAIDs in causing such reactions. High doses of any NSAID probably carry a greater risk of these reactions, although controlled clinical trials showing this do not exist in most cases. In considering the use of relatively large doses (within the recommended dosage range), sufficient benefit should be anticipated to offset the potential increased risk of GI toxicity.
Patients receiving non-steroidal anti-inflammatory agents, such as meclofenamate sodium, should be evaluated periodically to insure that the drug is still necessary and well tolerated (see other PRECAUTIONS, WARNINGS, and ADVERSE REACTIONS). Diarrhea, gastrointestinal irritation and abdominal pain may be associated with meclofenamate sodium therapy. Dosage reduction or temporarily stopping the drug have generally controlled these symptoms (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
Decreases in hemoglobin and/or hematocrit levels have occurred in approximately 1 of 6 patients, but rarely required discontinuation of meclofenamate sodium therapy. The clinical data revealed no evidence of increased chronic blood loss, bone marrow suppression, or hemolysis to account for the decreases in hemoglobin or hematocrit levels. Patients who are receiving long-term meclofenamate sodium therapy should have hemoglobin and hematocrit values determined if anemia is suspected on clinical grounds.
If a patient develops visual symptoms (see ADVERSE REACTIONS) during meclofenamate sodium therapy, the drug should be discontinued and the patient should have a complete ophthalmologic examination.
When meclofenamate sodium is used in combination with steroid therapy, any reduction in steroid dosage should be gradual to avoid the possible complications of sudden steroid withdrawal.
Adverse effects are seen more commonly in the elderly; therefore, a lower starting dose and careful follow-up are advised.
Evaluation of Patients with Heavy Menstrual Blood Loss
Prior to prescribing meclofenamate sodium for heavy blood flow and primary dysmenorrhea, a thorough risk/benefit assessment should be made that takes into account the results described in the CLINICAL PHARMACOLOGY section. It is recommended that meclofenamate sodium treatment not be prescribed for heavy menstrual flow without establishing its idiopathic nature. Spotting or bleeding between cycles should be evaluated fully and not treated with meclofenamate sodium. Worsening of menstrual blood loss or excessive blood loss failing to respond to meclofenamate sodium should also be evaluated by an appropriate work-up and not treated with meclofenamate sodium.
As with other non-steroidal anti-inflammatory drugs, borderline elevations of one or more liver tests may occur in some patients. These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. The SGPT (ALT) test is probably the most sensitive indicator of liver dysfunction. Meaningful (three times the upper limit of normal) elevations of SGPT or SGOT (AST) occurred in controlled clinical trials in less than 1% of patients. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more severe hepatic reaction while on therapy with meclofenamate sodium. Severe hepatic reactions, including jaundice and cases of fatal hepatitis, have been reported with other non-steroidal anti-inflammatory drugs. Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g.; eosinophilia, rash), meclofenamate sodium should be discontinued.
As with other non-steroidal anti-inflammatory drugs, long-term administration of meclofenamate sodium to animals has resulted in renal papillary necrosis and other abnormal renal pathology. In humans, there have been reports of acute interstitial nephritis with hematuria, proteinuria, and occasionally nephrotic syndrome.
A second form of renal toxicity has been seen in patients with prerenal conditions leading to a reduction in renal blood flow or blood volume, where the renal prostaglandins have a supportive role in the maintenance of renal perfusion. In these patients administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and may precipitate overt renal decompensation.
Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly. Discontinuation of NSAID therapy is typically followed by recovery to the pretreatment state.
Since meclofenamate sodium metabolites are eliminated primarily by the kidneys, patients with significantly impaired renal function should be closely monitored; a lower daily dosage should be employed to avoid excessive drug accumulation.
Patients receiving long-term meclofenamate sodium therapy should have hemoglobin and hematocrit values determined if signs or symptoms of anemia occur.
Low white blood cell counts were rarely observed in clinical trials. These low counts were transient and usually returned to normal while the patient continued on meclofenamate sodium therapy. Persistent leukopenia, granulocytopenia, or thrombocytopenia warrant further clinical evaluation and may require discontinuation of the drug.
When abnormal blood chemistry values are obtained, follow-up studies are indicated.
Elevations of serum transaminase levels and of alkaline phosphatase levels occurred in approximately 4% of patients. An occasional patient had elevations of serum creatinine or BUN levels.
Because serious GI tract ulceration and bleeding can occur without warning symptoms, physicians should follow chronically treated patients for the signs and symptoms of ulceration and bleeding and should inform them of the importance of this follow-up (see WARNINGS: Risk of GI Ulceration, Bleeding and Perforation with NSAID Therapy).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/7/2009
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