Celecoxib (Page 3 of 9)

5.15 Inflammation


The pharmacological activity of celecoxib in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions.

5.16 Concomitant NSAID Use


The concomitant use of celecoxib with any dose of a non- aspirin NSAID should be avoided due to the potential for increased risk of adverse reactions.

6 ADVERSE REACTIONS


Of the celecoxib-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of celecoxib of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received celecoxib at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.

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 adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

6.1 Pre-marketing Controlled Arthritis Trials

Table 1 lists all adverse events, regardless of causality, occurring in ≥2% of patients receiving celecoxibfrom 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group. Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence.

Table 1: Adverse Events Occurring in >2% of Celecoxib Patients from Pre-marketing Controlled Arthritis Trials

CBX N=4,146 Placeb o N=1,864 NAP N=1,366 DCF N=387 IBU N=345
Gastrointestinal AbdominalPain Diarrhea Dyspepsia Flatulence Nausea 4.1% 5.6% 8.8% 2.2% 3.5% 2.8% 3.8% 6.2% 1% 4.2% 7.7% 5.3% 12.2%3.6% 6% 9% 9.3% 10.9%4.1% 3.4% 9% 5.8% 12.8% 3.5% 6.7%
Bodyasawhole BackPain PeripheralEdema Injury-Accidental 2.8% 2.1% 2.9% 3.6% 1.1% 2.3% 2.2% 2.1% 3% 2.6% 1% 2.6% 0.9% 3.5% 3.2%
Central, Peripheral Nervoussystem Dizziness Headache 2%15.8% 1.7% 20.2% 2.6% 14.5% 1.3% 15.5% 2.3% 15.4%
Psychiatric Insomnia 2.3% 2.3% 2.9% 1.3% 1.4%
Respiratory Pharyngitis Rhinitis Sinusitis UpperRespiratory Infection 2.3% 2% 5% 8.1% 1.1% 1.3% 4.3% 6.7% 1.7% 2.4% 4% 9.9% 1.6% 2.3% 5.4% 9.8% 2.6% 0.6% 5.8% 9.9%
Skin Rash 2.2% 2.1% 2.1% 1.3% 1.2%

CBX = Celecoxib 100 to 200 mg twice daily or 200 mg once daily;

NAP = Naproxen 500 mg twice daily;

DCF = Diclofenac 75 mg twice daily;

IBU = Ibuprofen 800 mg three times daily.

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving celecoxib and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the celecoxib treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of celecoxib patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.

The following adverse reactions occurred in 0.1 to 1.9% of patients treated with celecoxib (100 to 200 mg twice daily or 200 mg once daily):

Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction
General : Allergy aggravated, allergic reaction, chest pain, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain.
Central, peripheral nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, paresthesia, vertigo
Hearing and vestibular : Deafness, tinnitus
Heart rate and rhythm : Palpitation, tachycardia
Liver and biliary : Hepatic function abnormal, SGOT increased, SGPT increased
Metabolic and nutritional : BUN increased, CPK increased, hypercholesterolemia, hyperglycemia, hypokalemia, NPN increased, creatinine increased, alkaline phosphatase increased, weight increased
Musculoskeletal : Arthralgia, arthrosis, myalgia, synovitis, tendinitis
Platelets (bleeding or clotting) : Ecchymosis, epistaxis, thrombocythemia,
Psychiatric : Anorexia, anxiety, appetite increased, depression, nervousness, somnolence
Hemic : Anemia
Respiratory : Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnea, laryngitis, pneumonia
Skin and appendages : Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, skin dry, sweating increased, urticaria
Application site disorders : Cellulitis, dermatitis contact
Urinary : Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus

The following serious adverse events (causality not evaluated) occurred in <0.1% of patients (cases reported only in post-marketing experience are indicated in italics):

Cardiovascular : Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis, vasculitis, deep venous thrombosis
Gastrointestinal : Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus
Liver and biliary : Cholelithiasis, hepatitis, jaundice, liver failure
Hemic and lymphatic : Thrombocytopenia, agranulocytosis, aplastic anemia, pancytopenia, leucopenia
Metabolic: Hypoglycemia, hyponatremia
Nervous : Ataxia, suicide, aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage [see Drug Interactions (7.1)]
Renal : Acute renal failure, interstitial nephritis
Skin: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis
General : Sepsis, sudden death, anaphylactoid reaction, angioedema

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