New Celebrex Label To Warn of Renal Events; Gastrointestinal Benefit Claim Removed

WASHINGTON, D.C.- The new FDA-approved warning labels accompanying the arthritis drug Celebrex will continue to educate patients and physicians of the potential risk of gastrointestinal events associated with the anti-inflammatory drug, and include new information for elderly patients concerning gastrointestinal and renal events.

According to the FDA's June 7 press release, the changes were based on the results of the Celecoxib Long-term Arthritis Safety Study (CLASS), which showed Celebrex does not have a safety advantage over other nonsteroidal anti-inflammatory drugs (NSAIDS) regarding the potential risk of gastrointestinal bleeding, ulceration or perforation.

CLASS was a double-blind perspective study consisting of …