FDA Calls for Strict Labeling Changes

posted on:
June 15, 2005

author:
Staff

 The FDA asked all manufacturers of NSAIDs to revise the labeling for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use. 

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 were the following:

• 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 listed below:

• Public Health Advisory
• FDA Press Release
• Questions and Answers
• Decision Memo – Analysis and Recommendations for Agency Action – COX-2 Selective and Non-selective NSAIDs (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
• Labeling Template
• Medication Guide PDF
• Over-the-Counter NSAID Products (6/15/2005)
• Supplemental Request Letter and Labeling Template
• 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) Table of Drug Products

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