The FDA has approved labeling changes for Celebrex (celecoxib) based on the results of the Celecoxib Long-term Arthritis Safety Study (CLASS). CLASS was a prospective double-blind randomized safety trial that evaluated approximately 4000 patients with osteoarthritis (OA) and rheumatoid arthritis (RA) treated with Celebrex 400 mg twice a day (twice the highest approved dose of Celebrex to treat RA) compared to approximately 4000 patients treated with standard doses of ibuprofen or diclofenac (nonsteroidal anti-inflammatory drugs.) The use of low-dose aspirin for cardiovascular prophylaxis (up to 325 mg/day) was permitted during the study.

FDA agreed with its Advisory Committee recommendations of February 7, 2001 that CLASS did not show a safety advantage in upper gastrointestinal (GI) events for Celebrex compared to either ibuprofen or diclofenac. Inclusion of patients on low-dose aspirin in the study was valuable for safety assessment of Celebrex in this important population of arthritis sufferers. However, the use of aspirin (a drug known to cause stomach ulcers and bleeding) may have obscured the ability to accurately compare the GI safety of Celebrex to other nonsteroidal anti-inflammatory drugs. The agency concluded that the drug labeling for Celebrex should continue to include the standard warning for doctors and their patients about risks associated with all NSAIDS, including risks of GI ulceration, bleeding and perforation. The labeling advises physicians prescribing and patients taking these drugs to be alert for ulceration and bleeding that can occur with or without warning.

The Agency also determined that valuable safety data from CLASS should be incorporated into the labeling. The overall safety of Celebrex at twice the highest approved dose for RA was similar to commonly used doses of ibuprofen and diclofenac. Despite the high dose used, the rates of hypertension, edema, and serious adverse events, including cardiovascular adverse events (such as heart attacks) were no higher in Celebrex treated patients compared to ibuprofen or diclofenac treated patients.

Patients taking low dose aspirin and Celebrex had a higher rate of upper GI events than those taking Celebrex alone.

The geriatric section of the labeling will include new information about the risk of serious GI and renal (kidney) effects in the elderly. Such findings have been reported with other NSAIDs as well, and it is known that the elderly are at higher risk of GI ulcers and bleeding.

Another observation reported in the labeling is that patients treated with Celebrex had fewer clinically relevant decreases in hemoglobin than patients taking ibuprofen or diclofenac.

Celebrex is manufactured by Pharmacia of Peapack, New Jersey. The drug was approved to treat rheumatoid arthritis and osteoarthritis in December l998.