What is Celebrex?
Sibutramine (Meridia® in the USA, Reductil® in Europe), usually as sibutramide hydrochloride monohydrate, is an orally administered agent for the treatment of obesity. It is an anorectic (i.e. it decreases appetite) although it also has antidepressant properties. It was approved by the Food and Drug Administration (FDA) in November 1997[1] for the treatment of obesity.
Sibutramine acts by increasing serotonin and nor adrenaline levels in the brain. The serotonergic action, in particular, is thought to influence appetite. Recognized side-effects are dry mouth, headache, constipation and insomnia. It may increase the blood pressure, and is therefore contraindicated in patients with arterial hypertension, or others in whom a rise in blood pressure would be harmful (e.g. patients with angina). Pulmonary hypertension, a problem in some other anorectics, is not a recognized side-effect.
A study is ongoing into reports of sudden death, heart failure, renal failure and gastrointestinal problems. Despite petitions[2], the drug has not been banned by the FDA, but was part of a Senate hearing in 2005.
Adverse effects of Celebrex?
Adverse effects
Aside from the incidence of gastric ulceration, celecoxib exhibits a similar adverse drug reaction (ADR) profile to other NSAIDs.
Gastrointestinal ADRs
In theory the COX-2 selectivity should result in a significantly lower incidence of gastrointestinal ulceration than traditional NSAIDs. The main body of evidence touted to support this theory were the preliminary (6 month) results of the Celecoxib Long-term Arthritis Safety Study (CLASS) as published in 2000, which demonstrated a significant reduction in the incidence of gastrointestinal ulceration in those taking celecoxib versus ibuprofen or diclofenac. (Silverstein et al, 2000) The final (12 month) results from the CLASS study, however, did not indicate any advantage of celecoxib over the other NSAIDs in the study. (Malhotra, Shafiq & Pandhi, 2004)
Cardiovascular risk
The withdrawal of rofecoxib from the market in 2004 due to an increased risk of adverse cardiovascular events led to the suspicion that this was a class effect. Indeed an increased risk of heart attack and stroke was found in a National Cancer Institute study studying the use of 400-800 mg celecoxib daily for the prevention of colorectal adenoma (relative risk 2.3-3.4 vs placebo). (Solomon et al., 2005)
There is still much conjecture, however, as to whether this risk is significant for the majority of patients being treated with lower doses for osteoarthritis.
Allergy
Celecoxib contains a sulfonamide moiety and may cause allergic reactions in those allergic to other sulfonamide-containing drugs. This is in addition to the contraindication in patients with severe allergies to other NSAIDs.
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