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Up until a December 17, 2004 announcement, Pfizer Inc. has been enjoying the success of its best-selling, blockbuster arthritis painkiller Celebrex. The tenth most popular drug in the United States, with annual sales of $2.7 billion, Celebrex has been prescribed to more than 27 million people in the U.S. since its 1999 emergence to the market. The future of the drug now remains unknown after Pfizer said it has found an increased risk of heart attacks in one of two long-term cancer prevention trials that was suspended when the Celebrex side effects were discovered.
The National Cancer Institute was conducting the study for Pfizer as part of an effort to find a new application for the drug. Instead, the Celebrex side effects were discovered in patients taking 400mg to 800mg of the drug daily. Compared to patients taking a placebo, the Celebrex side effects risks were 2.5 times greater.
Pfizer is the world''s largest pharmaceutical maker, but the discovery of Celebrex side effects could have a major impact on the future liability of the company. The pharmaceutical industry has been under heavy scrutiny since the September 30, 2004 recall announcement of Merck & Co.''s rival drug Vioxx. Vioxx was recalled after a study linked the drug to increased risk of heart attacks and stroke.
Regulators were already taking a closer look at the entire class of COX-2 painkillers, but Pfizer insisted there was an absence of Celebrex side effects similar to Vioxx as recently as December 6, 2004. In the time after the Vioxx recall, Celebrex sales had jumped, but experts were still concerned with possible Celebrex side effects. Public Citizen consumer group has been preparing a petition to the FDA for the immediate removal of Celebrex and Pfizer''s other COX-2 drug on the market Bextra.
The announcement of the Celebrex side effects immediately affected Pfizer''s stocks. According to Stefan Ingildsen of BankInvest in Copenhagen, which manages about $9 billion and holds shares of Pfizer, “the market sees a much larger risk today, not only about products in the pipeline but also products already on the market,” adding, “there''s very little incentive to invest in this sector at all at the moment.”
COX-2 inhibitors have become so popular because of their effectiveness in treating the pain of arthritis and other ailments without causing stomach upset and bleeding, as many other painkillers do. The drug class, which includes Vioxx, Celebrex and Bextra, was thought an advantage over older medications, but now experts are not clear why Vioxx and Celebrex side effects may raise the risk of heart attack or stroke. Since COX-2 inhibitors block a protein responsible for the health of blood vessels, they may promote the formation of blood clots, which would increase the incidence of heart attacks and strokes.
The FDA had already been planning on holding an advisory committee meeting in 2005 to review the safety of the COX-2 painkillers before Pfizer announced new Celebrex side effects were found. A couple weeks before the Celebrex side effects announcement the FDA said it was adding a warning to the labels of Bextra, warning of potential heart problems associated with the use of the drug in patients who have recently had heart bypass surgery.
The Vioxx recall prompted Congress to examine how the FDA monitors the risks of medicines, and the latest Celebrex side effects may further injure public confidence.
After COX-2 painkillers – Vioxx, Celebrex and Bextra- came under scrutiny when cardiovascular risks were associated to the drugs some drugmakers saw this as an opportunity to try to capitalize on the events.
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