COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

[4/7/2005] The Food and Drug Administration (FDA) has issued supplemental request letters to sponsors of all non-steroidal anti-inflammatory drugs (NSAID) requesting that they make labeling changes to their products. These letters include recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked 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. The Celebrex labeling will, in addition to the general labeling that will apply to all NSAIDs, also contain safety data from long-term treatment trials with celecoxib.

Manufacturers of non-prescription (over-the-counter) NSAIDs are 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 of the limited dose and duration of treatment of these products 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.

Further information regarding the decisions being announced and specific details regarding the individual products can be found within the documents posted on this Web page.

• Public Health Advisory (4/7/2005)
• FDA Press Release - FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (4/7/2005)
• Questions and Answers
• Decision Memo - Analysis and Recommendations for Agency Action - COX-2 Selective and Non-selective NSAIDs (PDF - 143KB) (issued 4/6/2005, posted 4/15/2005)
• COX-2 Selective Drugs (including Bextra, Celebrex, and Vioxx)
•  Prescription NSAID Products (6/15/2005)
  • Supplemental Request Letter (PDF - 45KB)
  • Labeling Template (PDF - 50KB)
  • COX-2 Medication Guide (PDF - 115KB)
• Over-the-Counter NSAID Products
  • New July 15, 2005. The agency has issued new supplemental labeling request letters for OTC NSAID products. The Agency received comments from industry regarding the June 14th supplemental labeling request letter and labeling template. Upon completion of our review of the comments, the Agency has decided to make revisions to the OTC labeling template and issue a new supplemental labeling request letter.
    • Revised Supplemental Request Letter and Labeling Template (PDF - 192KB) (7/18/2005)
  • Supplemental Request Letter and Labeling Template (PDF - 183KB) (6/15/2005) 
• Table of Drug Products - COX-2 Selective Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Prescription and Over-the-Counter (OTC) Non-selective NSAIDs Approved Under New Drug Application (NDA) Abbreviated New Drug Application (ANDA)

 COX-2 Selective Drugs

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Other Prescription Non-selective NSAIDs

• Healthcare Professional Sheet (4/7/2005)

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 COX-2 Selective Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Prescription and Over-the-Counter (OTC) Non-selective NSAIDs Approved Under New Drug Application (NDA) Abbreviated New Drug Application (ANDA)

COX-2 Selective NSAIDs

Non-selective NSAIDs