| On April 7, 2005, the Food and Drug Administration released the following statement regarding the COX-2 Inhibitor Bextra:
COX-2 Selective and
Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
The Food and Drug Administration (FDA) has asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market. FDA is also asking manufacturers of all marketed prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use.
Manufacturers of non-prescription (over-the-counter) NSAIDs are also being asked to revise their labeling to provide more specific information about the potential CV and GI risks of their individual products and remind patients that these products of the limited dose and duration of treatment in accordance with the package instructions.
In making these decisions, the Center for Drug Evaluation and Research (CDER) considered the risk/benefit profile for each of the drugs. Also considered was;
• review of the regulatory histories and new drug application (NDA) databases of the various NSAIDs,
• FDA and sponsor background documents prepared for the joint Advisory Committee meeting of FDA’s Arthritis and Drug Safety and Risk Management Advisory Committees, held February 16-18, 2005,
• all materials and data submitted by other stakeholders to the Advisory Committee meeting,
presentations made at the joint meeting
• the specific votes and recommendations made by the joint Committee.
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