The makers of Celebrex (celecoxib) do not have enough evidence to claim their popular arthritis drug is safer for the stomach than traditional non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.
The Arthritis Advisory Committee to the FDA met to discuss whether findings from Celebrex-maker Pharmacia's "CLASS" study proved that Celebrex is safer on the stomach than two NSAIDs, ibuprofen and diclofenac.
Celebrex, like Merck's Vioxx, is a selective COX-2 inhibitor. Other anti-inflammatory drugs also inhibit COX-2, which is an enzyme involved in inflammation, in addition to COX-1, which is thought to protect the lining of the stomach. Based on current estimates, there about 16,500 deaths per year in the US due to serious NSAID toxicity, according to the company.
Clinical trials that led to the approval of the COX-2 inhibitors suggested they were safer on the stomach, but regulators said the companies needed to conduct larger studies before they could drop a warning about gastrointestinal risks that all NSAIDS carry on their packaging.
The panel agreed that Pharmacia had not established a "clinically meaningful" safety advantage over NSAIDs and that data from the CLASS study would not support a superiority claim.
Although the trial showed an overall 2-fold reduction in gastrointestinal complications, that trend was reversed among subjects who also took low-dose aspirin. Many older people take low-dose aspirin daily to protect against heart attack.
Among aspirin takers, Pharmacia was unable to demonstrate safety superiority over ibuprofen or pooled NSAID data, including ibuprofen and diclofenac, FDA official Dr. James Witter told Reuters Health.
The CLASS study also did not establish a safety advantage over NSAIDs among patients with ulcer complications.
The panel advised that further studies should be done to better asses the risk of COX-2 specific inhibitors and NSAIDS when taken with aspirin but did not advise any labeling changes for Celebrex for the time being.
The product's labeling currently warns that the drug is not to be used as an aspirin substitute for cardiac protection.
Celebrex, approved in December 1998 to treat osteoarthritis and rheumatoid arthritis, was the first COX-2 specific inhibitor on the market.
Celebrex's approval was followed by the FDA's May 1999 clearance of Merck's Vioxx (rofecoxib), indicated to treat osteoarthritis, acute pain and painful menstruation.
Pharmacia's CLASS trial involved 8,000 mostly female patients who averaged 60 years of age and who had osteoarthritis or rheumatoid arthritis. The trial compared Celebrex at an "exaggerated" dose of 800 milligrams (mg) per day, or 4 times the recommended dose to treat osteoarthritis and twice the usual dose for rheumatoid arthritis, against normal doses of both ibuprofen and diclofenac.
Advisory Panel to the US Food and Drug Administration (FDA) Gaithersburg, MD, February 8, 2001
Celebrex is the number one anti-inflammatory drug so this is important information. Many people are taking this drug under the impression that it will reduce their risk of ulcers.
The market for analgesics is about TEN BILLION dollars per year. That is one big number. That is why this is an important drug to watch. It is important to remember that anytime you are dealing with numbers that large there will inevitably be corruption, greed and negative influences that are a part of the story if drugs are involved.
So ALWAYS be alert to deception. As one of my friends, Dr. Tom Stone, is fond of saying "The PLANET is RULED by GREED and DECEIT!"
Don't you find it interesting that Pharmacia, the drug's manufacturer can not even prove that this new drug is any less damaging than aspirin. That is supposed to be the huge advantage of this drug. It is supposed to cause less GI toxicity.
Celebrex has also been shown to reduce beneficial protaglandins and increase your risk for heart attack.
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