Pfizer Claims Celebrex Safety in September: Day Vioxx Recalled

Dec. 17, 2004 – On September 30, the day Merck & Co. announced the recall of its COX-2 drug, Vioxx, Pfizer issued a news release expressing confidence that Celebrex did not cause heart problems, as found in the case of Vioxx.

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

Following is the rest of the Pfizer statement on Celebrex and their second COX-2 drug, Bextra:

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.

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.

Important safety information

You should not take BEXTRA or CELEBREX if you've had allergic reactions to certain drugs called sulfonamides, aspirin or other arthritis medicines if you've had aspirin sensitive asthma, or are in late pregnancy.

BEXTRA is not recommended if you have advanced kidney disease. Tell your doctor if you have fluid retention problems. Be sure to tell your doctor if you are pregnant, or if you have kidney or liver problems.

In rare cases, serious stomach problems such as bleeding can occur without warning. Tell your doctor right away if you develop blisters in the mouth or a rash while taking BEXTRA, as it can be a sign of a serious skin reaction that may be life threatening. If you experience other unusual symptoms while taking BEXTRA or CELEBREX, tell your doctor immediately.

In clinical trials, the most common side effects with BEXTRA were headache, abdominal pain, indigestion, upper respiratory infection, nausea and diarrhea. The most common side effects in clinical trials with CELEBREX were indigestion, diarrhea and abdominal pain.

End of company statement