2004-09-30
Vioxx (valdecoxib) is a COX-2 inhibitor made by Merck & Co. When COX-2 inhibitors entered the market in 1999, the new generation of medications was deemed the “super aspirin” because it claimed to be safer than traditional NSAIDs like aspirin, ibuprofen, naproxen, etc.
When Merck abruptly pulled Vioxx off the shelves in September 2004, Merck had spent $78 million advertising the blockbuster drug which was supposed to protect the digestive tract – a common problem among NSAIDs. The Vioxx recall occurred because of the discovery that increased cardiovascular risks were present.
In addition, there is still significant controversy about how well Vioxx is actually able to protect the digestive tract over older medications. After an FDA panel met for three days to decide on the safety issues that surfaced after the Vioxx recall regarding the entire class of COX-2 drugs, the panel voted in favor of allowing a possible return of Vioxx in a close 17-15 vote. The FDA generally accepts its panel’s recommendations, though the panel did unanimously say cardiac risks still exist.