CELEBREX
Celebrex is manufactured jointly by Searle Pharmaceuticals and Pfizer Pharmaceuticals, and was launched in the United States in 1999 and has been marketed worldwide. Celebrex is the world's most-prescribed arthritis and pain-relief brand. Worldwide sales of Celebrex in 2003 topped $5 billion. Since Celebrex was launched in 1999, 27 million prescriptions for the drug have been written in the United States alone. Worldwide sales are unknown. In the past year, Celebrex sales have been rising by double digit percentage growths while its main competitor, Vioxx, has seen sales become flat amid safety concerns worried about the increased incidence of blood clots tied to strokes and heart attacks found in clinical studies. On September 30, 2004, Vioxx was recalled from the market due to a confirmed measure of an increased change of heart attack or stroke from using the drug. This development has seen Celebrex come under scrutiny for the same concerns and it has yet to be seen if Celebrex sales will continue to grow or level off.
FDA approved Celebrex (also known as celecoxib) in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the first COX-2 inhibitor drug, a kind of nonsteroidal anti-inflammatory drug (NSAID), approved by FDA and revolutionized the future of pain medications. When it was approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Since its inception, data has shown the rate of hospitalizations for gastrointestinal events associated with long-term arthritis treatment has declined significantly. However, health concerns relating to heart attacks and strokes were persistent.
After the withdrawal of Vioxx from the market due to the increased risk of heart attack and stroke associated with its use, Celebrex was put under increased scrutiny for any health related side effects it may cause because Celebrex is in the same COX-2 inhibitor class as Vioxx. On December 17, 2004, the FDA announced that it was halting the use of Celebrex in a clinical trial after Celebrex was also found to increase the risk of heart attacks among users.
Soon after, on December 20, 2004, Pfizer announced it was immediately stopping all advertising for Celebrex. The ban included all television, radio, newspaper and magazine advertising. Pfizer spent over $70 million advertising Celebrex to the U.S. consumers in the first nine months of 2004. Pfizer said it would keep Celebrex on the market and would continue to advertise the drug to doctors.
Currently, the FDA is examining information on Celebrex to determine if the drug should be removed from the market.
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