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Friday, October 22, 2004
Pfizer affirms safety of celecoxib capsules
In response to Merck & Co.’s announcement of the worldwide withdrawal of its COX-2 medicine rofecoxib, Pfizer Inc. issued a statement.
Pfizer said that over 27 million patients in the United States have been prescribed with celecoxib, which was approved by the U.S. Food and Drug Administration in 1998. In the Philippines, celecoxib was approved by the Bureau of Food and Drugs in 1999 for the treatment of osteoarthritis and rheumatoid arthritis. It has also been approved for acute pain. There have been several prescriptions of celecoxib in the Philippines since its launch in 1999.
“Pfizer is confident in the long-term cardiovascular safety of celecoxib,” said Dr. Joe Feczko, Pfizer’s president of worldwide development.
In a recent FDA-sponsored study of 1.4 million patients, those who received celecoxib demonstrated no increased risk of cardiac events.
“Patients taking COX-2 inhibitors may be confused and should speak with their doctors,” Feczko said. “Because of its outstanding long-term safety profile and broad indication base including osteoarthritis, rheumatoid arthritis and acute pain, celecoxib is an appropriate treatment alternative.”
Celecoxib 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 valdecoxib, its second COX-2 inhibitor, for use in osteoarthritis and rheumatoid arthritis. Valdecoxib’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.
(October 22, 2004 issue)
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