FDA is asking the manufacturers of all over-the-counter NSAIDs to revise their labels, as well, to include more specific information about the potential cardiovascular and gastrointestinal risks, and to provide information to assist consumers in the safe use of the medications.

The FDA announced a series of changes related to the marketing of other NSAID (non-steroidal anti-inflammatory drugs), as well, including several COX-2 prescription and non-prescription medications.

Black Box Warning for Celebrex

FDA asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label, and Pfizer has agreed to work with FDA to comply.

FDA also is asking manufacturers of all other prescription NSAIDs to revise their labels to include the boxed warning, highlighting the potential for increased risk of cardiovascular events and gastrointestinal bleeding associated with their use.

In addition, manufacturers of all prescription NSAIDs will be asked to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.

Vioxx Withdrawal Set Wheels in Motion

FDA is asking the manufacturers of all over-the-counter (OTC) NSAIDs to revise their labels, as well, to include more specific information about the potential CV and GI risks, and to provide information to assist consumers in the safe use of the medications. FDA also is asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA says it will carefully review any proposal from Merck for resumption of marketing of Vioxx.

Latest Scientific Data

These actions are based on the available scientific data, including data accumulated since the drugs were approved, says FDA. The FDA considered the presentations, discussions and recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven K. Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."

A list of NSAID products is available on the Internet.