Pfizer Affirms Celebrex Safety in response to withdrawal of Merck's Vioxx

Main Category: GastroIntestinal / Gastroenterology
Article Date: 01 Oct 2004 - 9:00 PDT

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In response to Merck & Co.'s announcement today of the worldwide withdrawal of its COX-2 medicine Vioxx, Pfizer Inc issued the following statement:

Over 27 million patients in the United States have been prescribed Celebrex (celecoxib), which was approved by the U.S. Food and Drug Administration in 1998.

"Pfizer is confident in the long-term cardiovascular safety of Celebrex," said Dr. Joe Feczko, Pfizer's president of worldwide development.

In a recent FDA-sponsored study of 1.4 million patients, those who received Celebrex demonstrated no increased risk of cardiac events.

"Patients taking COX-2 inhibitors may be confused and should speak with their doctors," Dr. Feczko said. "Because of its outstanding long-term safety profile and broad indication base including osteoarthritis, rheumatoid arthritis and acute pain, Celebrex is an appropriate treatment alternative."

Celebrex was the first COX-2 inhibitor, a class of medicine designed to relieve pain without the serious gastrointestinal side effects associated with older non-steroidal anti-inflammatory medicines. In 2001, Pfizer introduced Bextra (valdecoxib), its second COX-2 inhibitor, for use in osteoarthritis and rheumatoid arthritis. Bextra's cardiovascular safety profile is also well established in long-term studies.

Data show that since the introduction of COX-2 inhibitors, the rate of hospitalizations for gastrointestinal events associated with long-term arthritis treatment has declined significantly.

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