Celebrex (Celecoxib) Approved By FDA

This article is part of the Arthritis Archives.

Editor note: 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: January 3, 1999

Celebrex Approved

Celebrex (celecoxib), was approved on December 31, 1998 by the United States Food and Drug Administration (FDA) for the relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis.

Celebrex (generic name celecoxib), is a long-awaited treatment option for people suffering with arthritis. Celebrex is the first FDA approved medication in a new class of arthritis drugs known as COX-2 selective inhibitors.

Celebrex was created using advanced molecular technology and it's creators have high expectations for its use. Celebrex works by inhibiting the COX-2 enzyme which is involved in the pain and inflammation process. At therapeutic doses Celebrex does not inhibit the COX-1 enzyme which is involved in helping to maintain the stomach lining. NSAIDs (non-steroidal anti-inflammatory drugs), inhibit both COX-1 and COX-2 enzymes, therefore they have the desired effect of treating pain and inflammation but also may damage the stomach lining and lead to ulcers.

COX-2 Selective Drugs

With the development of Celebrex and future COX-2 selective drugs, the intent is that gastrointestinal side effects associated with existing NSAIDS will be lessened if not eliminated.

Celebrex was tested in clinical trials involving more than 13,000 patients and healthy persons, including 50 different studies in 23 countries. Celebrex was demonstrated to be as effective as prescription-strength naproxen in treating arthritis pain and inflammation. In patients with osteoarthritis, Celebrex improved pain, stiffness, and functions such as walking and bending among others. Celebrex was associated with significantly fewer upper gastrointestinal ulcers than either naproxen or ibuprofen in clinical studies.

With the approval of Celebrex however, the FDA warned that it is not definite that Celebrex will cause less gastrointestinal distress than existing NSAIDs. Long-term studies must be done which show the long-term effect of the drug. For now Celebrex will carry the same warnings on its label as all other NSAIDs.

GI Side Effects

p]In clinical studies, the most common gastrointestinal side effects of Celebrex included:

• dyspepsia
• diarrhea
• abdominal pain

Discontinuing the use of Celebrex due to each of these was less than one percent. Even though Celebrex is touted as having less risk for stomach ulcers, serious gastrointestinal ulcerations can develop without forewarning. Both physicians and patients should remain aware of symptoms of GI bleeding.

Patients with known allergies to celecoxib, sulfonamides, aspirin, or NSAIDs should not use Celebrex. The new drug will be available by prescription in early 1999. The recommended dose for osteoarthritis is 200 mg. daily given as a single dose or 100 mg. twice a day. For rheumatoid arthritis the recommended dose is 100 to 200 mg. twice daily.

Related Resources - Celebrex / Celecoxib

Celebrex (celecoxib)

COX-2 Selective Inhibitors

NSAIDs (non-steroidal anti-inflammatory drugs)

Related Resources - Rheumatoid Arthritis / Osteoarthritis

Rheumatoid Arthritis or Osteoarthritis: Which is it?

Osteoarthritis

Rheumatoid Arthritis

_{Source: FDA Approves Celebrex For OA and RA, PRNewswire, 12/31/98
First published: 1/03/1999}