Bextra Lawyer: FDA Bextra Recall and Celebrex Black Box Warning

Your experienced Bextra attorney provides the following offical FDA press release concerning the Bextra Recall and the Black Box Celebrex Warning. If you or a loved one have been harmed by Bextra, complete this simple form for your FREE case review.

FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The Food and Drug Administration (FDA) today announced a series of important changes relating to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications. A list of these products is available on the Internet at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.

"Today's actions protect 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."

FDA has demanded Pfizer, Inc. to withdraw Bextra (valdexocib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Makers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling 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.

In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already discusses 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 will carefully review any proposal from Merck to resume marketing of Vioxx.

These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully 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.

To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.

Additional information about today's announcements is available on FDA's Web site at www.fda.gov/cder. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).

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April 7, 2005

Weitz & Luxenberg is no longer accepting Bextra cases.

see also:

FDA Talk Papers Bextra Lawyers - FDA Talk Papers Dec 2004
Bextra Recall FDA Talk Papers

Pfizer Response Bextra Lawyers - Pfizer Response: Bextra Recall
Bextra Recall Pfizer Response: Bextra Withdrawl

About the Bextra Recall Bextra lawyers - about the FDA Bextra recall
Bextra Withdrawal: Letter to clients about the FDA Bextra recall