Mobic Warnings
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Mobic Information
Mobic Warnings
Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation:
Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (Anti-Inflammatory Drugs">NSAIDs). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during Anti-Inflammatory Drugs">NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI symptoms.
Patients should be informed about the signs and/or symptoms of serious GI toxicity and the steps to take if they occur. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only one in five patients who develop a serious upper GI adverse event on Anti-Inflammatory Drugs">NSAID therapy is symptomatic. It has been demonstrated that upper GI ulcers, gross bleeding or perforation, caused by Anti-Inflammatory Drugs">NSAIDs, appear to occur in approximately 1% of the patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue thus, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
Anti-Inflammatory Drugs">NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high-risk patients, alternate therapies that do not involve Anti-Inflammatory Drugs">NSAIDs should be considered.
Studies have shown that patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use Anti-Inflammatory Drugs">NSAIDs, have a greater than 10-fold risk for developing a GI bleed than patients with neither of these risk factors. In addition to a past history of ulcer disease, pharmacoepidemiological studies have identified several other co-therapies or co-morbid conditions that may increase the risk for GI bleeding such as: treatment with oral corticosteroids, treatment with anticoagulants, longer duration of Anti-Inflammatory Drugs">NSAID therapy, smoking, alcoholism, older age, and poor general health status.
Anaphylactoid Reactions
As with other Anti-Inflammatory Drugs">NSAIDs, anaphylactoid reactions have occurred in patients without known prior exposure toMobic. Mobic should not be given to patients with the aspirin triad. This symptom complex typicallyoccurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe,potentially fatal bronchospasm after taking aspirin or other Anti-Inflammatory Drugs">NSAIDs (see PRECAUTIONS, Pre-existing Asthma). Emergency help should be sought in cases where an anaphylactoidreaction occurs.
Advanced Renal Disease
In cases with advanced kidney disease, treatment with Mobic is not recommended. If Anti-Inflammatory Drugs">NSAID therapy must be initiated, close monitoring of the patient's kidney function is advisable (see Precautions, Renal Effects).
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