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Celecoxib (Celebrex) Linked to Multiple Adverse Events
On July 29, the FDA approved protection labeling revisions for the nonsteroidal anti-inflammatory (NSAID) drug celecoxib (Celebrex capsules, made by Pfizer Epidemic Pharmaceuticals) to tip off of contraindications and warnings associated with this class of drugs and to call the penury to minify its fritter away to the lowest efficient dose in return the shortest feasible duration.
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Consume of a NSAID almost identical to celecoxib on pain government during the initial 10 to 14 days after coronary artery route insert (CABG) surgery has been linked to an increased hazard for myocardial infarction (MI) and slam; from of celecoxib in this locale is hence contraindicated.
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The FDA also warned that chronic need of celecoxib may be linked to an increased risk in the service of poker-faced and potentially fateful cardiovascular thrombotic events, MI, and stroke. As with other NSAIDs, these risks may snowball in the adjacency of existing cardiovascular murrain and/or affiliated chance factors.
The lesson was based on results of the Tabooing of Intermittent Colorectal Adenomas with Celecoxib trial in 1,356 patients, showing that capitalize on of 400 mg of celecoxib twice regular was linked to a 3.4-fold increment in the composite danger of cardiovascular death, MI, or flourish, comparable to placebo (95% self-assurance delay [CI], 1.4 - 8.5). In patients receiving 200 mg of celecoxib twice routine, the relative gamble was 2.4 (95% CI, 1.0 - 6.4).
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The FDA notes that there is no in concordance indication that concurrent use of low-dose aspirin mitigates the increased hazard for dangerous cardiovascular thrombotic events associated with celecoxib use.
Also, data from the Celecoxib Long-Term Arthritis Shelter Study (CATEGORY) of 8,000 patients attired in b be committed to linked concomitant play of low-dose aspirin and 400 mg of celecoxib twice continually to an increased chance during critical gastrointestinal adverse events compared with celecoxib alone (2.19% vs 0.78%). This chance was to boot increased in the old-fogyish (3.06% vs 1.40%).
A 400-mg administer of celecoxib twice regularly is twofold and fourfold the recommended dosage in requital for rheumatoid arthritis and osteoarthritis, respectively, and the approved prescribe in search familial adenomatous polyposis.
Unstatic retention and edema possess also been observed in patients receiving NSAIDs, such as celecoxib. In the BIRTH chew over, the Kaplan-Meier cumulative rates of beside the point edema at nine months in patients receiving 400 mg of celecoxib twice habitually, 800 mg of ibuprofen three times daily, and 75 mg of diclofenac twice daily were 4.5%, 6.9%, and 4.7%, respectively.
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The FDA advises that celecoxib be prescribed with alertness in patients with running retention or pith failure. Because concurrent use of NSAIDs may cripple feedback to treatment with thiazides or wind diuretics, tight monitoring of blood distress is recommended.
In the CLASS writing-room, hypertension was observed in 2.4%, 4.2%, and 2.5%, individually, in patients receiving celecoxib, ibuprofen, and diclofenac.
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Celecoxib and other NSAIDs are also associated with an increased risk for earnest and potentially fatal gastrointestinal adverse events, markedly in the elderly. Bleeding, ulceration, and perforation of the tolerate or intestines may manifest itself at any over and over again during remedy and without forewarning symptoms; just a person in five patients who develop a crucial blue bloods gastrointestinal territory adverse result while receiving NSAID cure is symptomatic.
The FDA notes that the gamble of developing a gastrointestinal bleed is 10-fold greater in patients with a prior ancient history of peptic carbuncle condition and/or gastrointestinal bleeding, and NSAIDs should for that reason be prescribed with maximum discretion in this population.
Other factors that grow the hazard of bleeding encompass concomitant purchase of said corticosteroids, anticoagulants, longer duration of group therapy, smoking, moonshine consumption, advanced years, and meagre run-of-the-mill robustness status. Because most unguarded reports of poisonous gastrointestinal events are in golden-agers or debilitated patients, extra worry should be taken in treating this population.
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Papillary necrosis and other renal injuries fool been observed with long-term provision of celecoxib and other NSAIDs. In patients for whom renal prostaglandins maintain a reparative duty in the conservation of renal perfusion, NSAIDs may producer a dose-dependent reduction in prostaglandin institution that may trigger apparent renal decompensation.
Patients with impaired renal job, magnanimity nonentity, liver dysfunction, the hoary, and those fascinating diuretics and angiotensin-converting enzyme inhibitors are at greatest imperil in requital for this reaction. Discontinuation of NSAID analysis is normally followed by way of rescue to the pretreatment state.