Pfizer Acted Responsibly In Sharing Celebrex Alzheimer's Study Data With FDA
Public Citizen Charge is Misleading and Unfair to Patients
Pfizer Inc said that it remains confident in its COX-2 medicines as important treatment options for arthritis patients and that it has acted responsibly in sharing all appropriate data with the U.S. food and Drug Administration.
Pfizer vigorously refutes claims by Public Citizen that safety data from a 1999 Celebrex study in Alzheimer's patients were "undisclosed." The study was monitored by an independent panel of safety experts, an abstract of the results was presented at a scientific congress in 2000, and the completed study report was submitted to the FDA in June 2001.
"Pfizer acted responsibly in sharing this information in a timely manner with the FDA," said Dr. Joseph Feczko, Pfizer president of worldwide development.
In fact, this single study is only one piece of information in the vast amount of clinical trial and other data supporting the safety of Celebrex in arthritis patients. The 12-month study, which was designed to assess the potential of Celebrex in slowing Alzheimer's disease progression, showed that Celebrex did not significantly influence the course of the disease.
On February 16, an FDA advisory committee will begin a rigorous scientific evaluation of the risks and benefits of all COX-2 medicines, including Celebrex and Bextra. Pfizer has provided the agency with an extensive analysis of all available safety data for its COX-2 medicines and continues to cooperate fully with worldwide regulatory authorities.
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