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Mobic

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Mobic

Side Effects
Interactions

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

Adults

Osteoarthritis and Rheumatoid Arthritis

The MOBIC Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with MOBIC 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with MOBIC 15 mg/day. MOBIC at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo- and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across MOBIC trials.

A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of MOBIC with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of MOBIC with placebo.

Table 1a depicts adverse events that occurred in ≥ 2% of the MOBIC treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥ 2% of the MOBIC treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

Table 1a : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial

  Placebo MOBIC 7.5 mg daily MOBIC 15 mg daily Diclofenac 100 mg daily
No. of Patients 157 154 156 153
Gastrointestinal 17.2 20.1 17.3 28.1
  Abdominal pain 2.5 1.9 2.6 1.3
  Diarrhea 3.8 7.8 3.2 9.2
  Dyspepsia 4.5 4.5 4.5 6.5
  Flatulence 4.5 3.2 3.2 3.9
  Nausea 3.2 3.9 3.8 7.2
Body as a Whole
  Accident household 1.9 4.5 3.2 2.6
  Edema1 2.5 1.9 4.5 3.3
  Fall 0.6 2.6 0.0 1.3
  Influenza-like symptoms 5.1 4.5 5.8 2.6
Central and Peripheral Nervous System
  Dizziness 3.2 2.6 3.8 2.0
  Headache 10.2 7.8 8.3 5.9
Respiratory
  Pharyngitis 1.3 0.6 3.2 1.3
  Upper respiratory tract infection 1.9 3.2 1.9 3.3
Skin
  Rash2 2.5 2.6 0.6 2.0
1WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined
2WHO preferred terms rash, rash erythematous, and rash maculo-papular combined

Table 1b : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in two 12-Week Rheumatoid Arthritis Placebo-Controlled Trials

  Placebo MOBIC 7.5 mg daily MOBIC 15 mg daily
No. of Patients 469 481 477
Gastrointestinal Disorders 14.1 18.9 16.8
  Abdominal pain NOS2 0.6 2.9 2.3
  Dyspeptic signs and symptoms1 3.8 5.8 4.0
  Nausea2 2.6 3.3 3.8
General Disorders and Administration Site Conditions
  Influenza-like illness2 2.1 2.9 2.3
  Infection and Infestations
  Upper respiratory tract infections-pathogen class unspecified1 4.1 7.0 6.5
Musculoskeletal and Connective Tissue Disorders
  Joint related signs and symptoms1 1.9 1.5 2.3
Nervous System Disorders
  Headaches NOS2 6.4 6.4 5.5
Skin and Subcutaneous Tissue Disorders
  Rash NOS2 1.7 1.0 2.1
1MedDRA high level term (preferred terms): dyspeptic signs and symptoms (dyspepsia, dyspepsia aggravated, eructation, gastrointestinal irritation), upper respiratory tract infections-pathogen unspecified (laryngitis NOS, pharyngitis NOS, sinusitis NOS), joint related signs and symptoms (arthralgia, arthralgia aggravated, joint crepitation, joint effusion, joint swelling)
2MedDRA preferred term: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS

The adverse events that occurred with MOBIC in ≥ 2% of patients treated short-term (4 to 6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 2.

Table 2 : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials

  4 to 6 Weeks Controlled Trials 6 Month Controlled Trials
MOBIC 7.5 mg daily MOBIC 15 mg daily MOBIC 7.5 mg daily MOBIC 15 mg daily
No. of Patients 8955 256 169 306
Gastrointestinal 11.8 18.0 26.6 24.2
  Abdominal pain 2.7 2.3 4.7 2.9
  Constipation 0.8 1.2 1.8 2.6
  Diarrhea 1.9 2.7 5.9 2.6
  Dyspepsia 3.8 7.4 8.9 9.5
  Flatulence 0.5 0.4 3.0 2.6
  Nausea 2.4 4.7 4.7 7.2
  Vomiting 0.6 0.8 1.8 2.6
Body as a Whole
  Accident household 0.0 0.0 0.6 2.9
  Edema1 0.6 2.0 2.4 1.6
  Pain 0.9 2.0 3.6 5.2
Central and Peripheral Nervous System
  Dizziness 1.1 1.6 2.4 2.6
  Headache 2.4 2.7 3.6 2.6
  Hematologic Anemia 0.1 0.0 4.1 2.9
  Musculoskeletal
  Arthralgia 0.5 0.0 5.3 1.3
  Back pain 0.5 0.4 3.0 0.7
  Psychiatric Insomnia 0.4 0.0 3.6 1.6
  Respiratory Coughing 0.2 0.8 2.4 1.0
  Upper respiratory tract infection 0.2 0.0 8.3 7.5
Skin
  Pruritus 0.4 1.2 2.4 0.0
  Rash2 0.3 1.2 3.0 1.3
  Urinary Micturition frequency 0.1 0.4 2.4 1.3
  Urinary tract infection 0.3 0.4 4.7 6.9
1WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined
2WHO preferred terms rash, rash erythematous, and rash maculo-papular combined

Higher doses of MOBIC (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of MOBIC should not exceed 15 mg.

Pediatrics

Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to MOBIC with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study. The adverse events observed in these pediatric studies with MOBIC were similar in nature to the adult clinical trial experience, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials. Rash was reported in seven ( < 2%) patients receiving MOBIC. No unexpected adverse events were identified during the course of the trials. The adverse events did not demonstrate an age or gender-specific subgroup effect.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving MOBIC in clinical trials involving approximately 16,200 patients.

Body as a Whole allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase
Cardiovascular angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis
Central and Peripheral Nervous System convulsions, paresthesia, tremor, vertigo
Gastrointestinal colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative
Heart Rate and Rhythm arrhythmia, palpitation, tachycardia
Hematologic leukopenia, purpura, thrombocytopenia
Liver and Biliary System ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis
Metabolic and Nutritional dehydration
Psychiatric abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence
Respiratory asthma, bronchospasm, dyspnea
Skin and Appendages alopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria
Special Senses abnormal vision, conjunctivitis, taste perversion, tinnitus
Urinary System albuminuria, BUN increased, creatinine increased, hematuria, renal failure

Post Marketing Experience

The following adverse reactions have been identified during post approval use of MOBIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug. Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Read the Mobic (meloxicam) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

See also CLINICAL PHARMACOLOGY.

ACE-inhibitors

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

Aspirin

When MOBIC is administered with aspirin (1000 mg three times daily) to healthy volunteers, an increase in the AUC (10%) and Cmax (24%) of meloxicam was noted. The clinical significance of this interaction is not known; however, as with other NSAIDs concomitant administration of meloxicam and aspirin is not generally recommended because of the potential for increased adverse effects.

Concomitant administration of low-dose aspirin with MOBIC may result in an increased rate of GI ulceration or other complications, compared to use of MOBIC alone. MOBIC is not a substitute for aspirin for cardiovascular prophylaxis.

Diuretics

Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. However, studies with furosemide agents and meloxicam have not demonstrated a reduction in natriuretic effect. Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of meloxicam. Nevertheless, during concomitant therapy with MOBIC, patients should be observed closely for signs of renal failure [see WARNINGS AND PRECAUTIONS], as well as to ensure diuretic efficacy.

Lithium

In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 to 1072 mg twice daily with meloxicam 15 mg every day as compared to subjects receiving lithium alone. These effects have been attributed to inhibition of renal prostaglandin synthesis by MOBIC. Closely monitor patients on lithium treatment for signs of lithium toxicity when MOBIC is introduced, adjusted, or withdrawn.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Therefore, NSAIDs may reduce the elimination of methotrexate, thereby enhancing the toxicity of methotrexate. Use caution when MOBIC is administered concomitantly with methotrexate [see CLINICAL PHARMACOLOGY].

Cyclosporine

MOBIC, like other NSAIDs, may affect renal prostaglandins, thereby altering the renal toxicity of certain drugs. Therefore, concomitant therapy with MOBIC may increase cyclosporine's nephrotoxicity. Use caution when MOBIC is administered concomitantly with cyclosporine.

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.

Monitor anticoagulant activity, particularly in the first few days after initiating or changing MOBIC therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding than with the use of either drug alone. Use caution when administering MOBIC with warfarin since patients on warfarin may experience changes in INR and an increased risk of bleeding complications when a new medication is introduced [see CLINICAL PHARMACOLOGY].

Kayexalate® (sodium polystyrene sulfonate)

Cases of intestinal necrosis (possibly fatal) have been described in patients who received concomitant sorbitol and Kayexalate® (sodium polystyrene sulfonate). Due to the presence of sorbitol in MOBIC Oral Suspension, use with Kayexalate® is not recommended.

Read the Mobic Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
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