Celebrex was released by Pfizer Inc. over a decade ago for the treatment of arthritis and menstrual pain. Celebrex, the brand name for celecoxib, is a nonsteroidal anti-inflammatory drug (NSAID), similar to ibuprofen (Advil) or naproxen (Aleve). Since its introduction into the world market, nearly 30 million people have taken the drug thanks to intense marketing direct to consumers and doctors. On August 1, 2005, Celebrex was also approved for the treatment of pain associated with ankylosing spondylitis – a type of arthritis that can be serious and affects the spinal area.
The U.S. FDA (Food and Drug Administration) required the manufacturer to add a new warning to the Celebrex label, and it was changed to reflect the increased risk of cardiovascular (CV) events. The new warning is a “black-box” warning – the highest level of caution the FDA expresses before pulling a drug off the market, and it means that the warning will display prominently on all Celebrex containers in a black box. The FDA has requested increased warnings on all NSAIDs, including Advil and Aleve, which state the risks of CV events and also major gastrointestinal (GI) problems such as stomach bleeding.
Still, all COX-2 inhibitors, including Celebrex – a class of NSAIDs that is prescription-only – are being more heavily studied because they appear to have a higher risk of CV events than just ibuprofen. Vioxx and Bextra, another Pfizer drug, have already been removed from the market because of their unacceptably high risks for CV events and skin reactions. Celebrex is currently one step away from that. Detailed research and clinical trials are underway to further understand its side effects and those of other COX-2 inhibitors, but results of some trials aren’t expected until 2010. In 2008, Celebrex was one of the drugs doctors surveyed said they would not take themselves.