Celebrex (celecoxib) is part of the COX-2 inhibitor drug class, made by Pfizer Inc. When Celebrex entered the U.S. market in 1999, it did not take long before sales of the arthritis painkiller took off, quickly becoming a blockbuster drug. Celebrex, and other COX-2 drugs, were touted as a superior drug to older medicines because of its ability to protect the digestive tract, unlike older medications. Experts have estimated more than 100,000 people are hospitalized every year because of drug induced ulcers, which COX-2 drugs like Celebrex were supposed to eliminate.
There continues to be significant controversy regarding how well Celebrex and other COX-2 drugs really do protect the digestive tract, and some researchers have maintained Celebrex is no better than traditional NSAIDs, like aspirin, ibuprofen, etc. After Merck & Co. announced its COX-2 drug Vioxx was being recalled in September 2004 because of increased risks of heart attacks and strokes, Pfizer continued to maintain that Celebrex did not carry the same risks, increasing its direct-to-consumer advertising efforts to communicate that message.
Pfizer spent $71 million advertising Celebrex, according to TMS Media Intelligence, from the start of 2004 up to Vioxx’s September recall. A study was halted when cardiovascular risks were also linked to Celebrex, despite company claims up to that point denying a connection, and Pfizer agreed to an FDA request to halt its advertising efforts until safety concerns were addressed. After an FDA committee met for three days to discuss the future of Celebrex and other COX-2 drugs, the panel did not say Celebrex is safe, but did say the drug should remain on the market with strong warnings about heart attacks and strokes.
Celebrex Side Effects
In 2004, 36 million prescriptions were filled for Pfizer Inc.’s blockbuster arthritis painkiller Celebrex and its other drug in the same COX-2 family class, Bextra. Celebrex’s popularity was greatly attributed to the aggressive advertising strategies. According to TMS Media Intelligence, Pfizer spent $71 million advertising Celebrex from the beginning of 2004 through the September 2004 announcement that its competitor drug Vioxx was being recalled from the market because of heart attacks and strokes.
Cardiovascular Celebrex side effects concerns immediately arose after the Vioxx recall because experts did not know if the events signified a class wide effect. Pfizer claimed there were no heart attack and stroke Celebrex side effects, continuing to reassure the public that its drug was different from Vioxx. Just after the Vioxx recall, similar concerns regarding Celebrex side effects resulted in a study being halted. In February 2005, an FDA panel met in a three-day meeting to discuss, among various COX-2 concerns, Celebrex side effects. Members of the advisory committee criticized Pfizer for lacking long-term safety data about Celebrex side effects. The panel decided despite the heart attack and stroke Celebrex side effects risks, the drug should remain on the market with strong warnings about the potential effects.
Celebrex warnings of heart attacks and strokes shortly followed the September 2004 Vioxx recall announcement. At the time, Celebrex maker Pfizer Inc. had been denying concerns that cardiovascular Celebrex warnings would be announced among speculation that the Vioxx side effects were indicative of a class wide effect.
In response to the Vioxx recall, a special FDA advisory panel decided to meet for a three-day meeting to deal with safety issues that had surfaced as a result, creating speculation that stronger Celebrex warnings could be issued. After meeting in February 2005, the panel, while acknowledging strong Celebrex warnings should exist, recommended the drug stay on the market. The FDA is expected to put the Celebrex warning in the form of a “black box,” the most stringent FDA issued drug warning.