The FDA has approved labeling changes for Celebrex (celecoxib) based on the results of the Celecoxib Long-Term Arthritis Safety Study (CLASS).
CLASS evaluated about 4,000 people with osteoarthritis (OA) and rheumatoid arthritis (RA) treated with Celebrex at doses of 400 mg twice a day (twice the highest approved dose of Celebrex to treat RA), compared to about 4,000 people treated with standard doses of ibuprofen or diclofenac. These are non-steroidal anti-inflammatory drugs (NSAIDs).
The use of low-dose aspirin for prevention of heart attack and stroke (up to 325 milligrams per day) was permitted during the study.
The results of the CLASS study did not support a change in the label related to serious gastrointestinal (GI) events, but important information about the drug was obtained. Inclusion of patients on low-dose aspirin in the study was valuable for the safety assessment of Celebrex. But 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 NSAIDs.
The agency concluded that the drug labeling for Celebrex should continue to include the standard warning about risks associated with all NSAIDS, including risks of GI ulceration, bleeding and perforation.
The FDA also determined that safety data from CLASS should be incorporated into the labeling. The overall safety of Celebrex at twice the highest approved dose for rheumatoid arthritis was similar to commonly used doses of ibuprofen and diclofenac. Despite the high dose used, the rates of hypertension, swelling, and serious adverse events, including cardiovascular problems such as heart attacks, were no higher in people treated with Celebrex than in people treated with ibuprofen or diclofenac. People 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 kidney effects in elderly people. Such findings have also been reported with other NSAIDs, and it is known that elderly people are at higher risk of GI ulcers and bleeding. Another observation reported in the labeling is that patients treated with Celebrex experienced less anemia than patients taking ibuprofen or diclofenac.
Pharmacia of Peapack, N.J., manufactures Celebrex. The drug was approved to treat rheumatoid arthritis and osteoarthritis in 1998.
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