This article is part of the Arthritis Archives.
Editor note: Celebrex (celecoxib) was approved on December 31, 1998 by the FDA for the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis. On 04/07/2005, Following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. See: Questions & Answers: FDA Actions On COX-2 Inhibitors & NSAIDs
Dateline: December 2, 1998
Celebrex Unanimously Recommended
On December 1, 1998, the FDA advisory panel unanimously recommended the approval of Celebrex for the treatment of osteoarthritis and rheumatoid arthritis.
Celebrex, generically known as celecoxib, is manufactured by Searle. Celebrex (celecoxib) is the first medication in a class of new arthritis drugs called COX-2 selective inhibitors seeking FDA approval.
In 1990 scientists revealed that there are two types of COX (cyclo-oxygenase), the enzyme involved in the inflammatory process. COX-2 is associated with inflammation while COX-1 is involved with protecting the stomach lining. At that time scientists theorized that a drug which could specifically target COX-2 would work against pain and inflammation while not disturbing the stomach. Following this discovery, a half dozen drug manufacturers rushed to develop such a drug and be the first one marketed. Besides Searle, Merck and Monsanto are among the drug companies developing a COX-2 inhibitor. Merck's version of the COX-2 inhibitor is known as Vioxx (rofecoxib).
NSAIDs
Millions of people currently turn to aspirin or select from the extensive list of NSAIDs (nonsteroidal anti-inflammatory drugs) to battle arthritis, ordinary aches and pains, and other painful conditions.
Searle representatives contend that Celebrex is safer and has fewer incidences of stomach distress than many currently available painkillers. To determine safety, Searle gave 4,700 patients endoscopies to see if ulcers were forming even before symptoms were presented. About 25-40 percent of patients taking ibuprofen or naproxen showed mini-ulcers compared to 5-10 percent of Celebrex patients. NSAIDs such as ibuprofen and diclofenac are the cause of 107,000 hospitalizations in the United States each year and are responsible for 16,500 deaths.
Studies
In studies of 13,000 patients which analyzed effectiveness, Celebrex worked nearly as well as prescription-strength naproxen against osteoarthritis. Against rheumatoid arthritis, Celebrex worked almost as well as diclofenac.
Though FDA advisors recommended approval of Celebrex, they were cautious. The advisors expressed concern that although Celebrex is expected to have less side effects, few people have taken it long enough to determine its long-term safety. The advisory panel decided that Celebrex does not need the standard ulcer warning which is given to other painkillers, but remained unsure of what warning to appropriately give the new drug.
Related Resources - Celebrex / Celecoxib
Related Resources - Osteoarthritis / Rheumatoid Arthritis
Sources: New, Safer Arthritis Drug Closer To Approval, Reuters 12/1/98; FDA Panel Approves Arthritis Drug, AP Online 12/2/98
First published; 12/02/1998
