The History of COX-2 Inhibitors
By Donna Rae Siegfried
The COX-2s – called “next-generation nonsteroidal anti-inflammatory drugs (NSAIDs)" – were touted as having the same pain-fighting benefits as traditional NSAIDs, but with a protective effect on the stomach. The protection was expected to potentially eliminate serious gastrointestinal side effects, including bleeding or perforated ulcers, which commonly occurred with long-term use of traditional NSAIDs, such as aspirin and diclofenac (Voltaren). The rise of COX-2s was meteoric and unprecedented; the downfall has been equally steep.
1998: Pfizer’s celecoxib (Celebrex) was the first COX-2 on the market.
1999: Rofecoxib (Vioxx) is the second COX-2 on the market.
2000: Sales of COX-2s skyrocket, and the first report of a possible link between rofecoxib and heart problems surfaces.
2001: The FDA Arthritis Advisory Committee meets to review studies of Celebrex and Vioxx.
2002: Valdecoxib (Bextra) is the third COX-2 to enter market. The FDA calls for labeling changes to Vioxx to reflect increased risk of heart attack and stroke.
2003: Sales of all COX-2s continue the decline that started in 2001, as concern increases.
2004: Merck voluntarily pulls Vioxx from market.
2005: Bextra is removed from market.
2006: FDA orders black box warnings about cardiovascular risks for all prescription and nonprescription NSAIDs.
2007: Merck’s second COX-2, etoricoxib (Arcoxia), fails to get FDA approval for marketing in the U.S.
