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FDA sends Pfizer Celebrex label change proposals

June 16, 2005

The FDA sent proposed label changes to Pfizer Inc., maker of the controversial painkiller Celebrex, because of heart and bleeding risks associated to the drug.

The new warnings were delivered to makers of all prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs include recently recalled drugs Vioxx and Bextra. The FDA called for stronger warnings in April after Pfizer suspended sales of Bextra when links to cardiovascular effects and a rare skin reaction were discovered.

An FDA spokeswoman said the agency will monitor how companies phrase and display advisories. Celebrex, and other prescription NSAIDs, will be required to carry the FDA's most severe warnings called "black box" warnings. Warnings will include risks of heart disease, gastrointestinal bleeding and include a description of the early symptoms of Stevens-Johnson Syndrome. A rare skin condition, the use of the drugs can cause it to develop, part of the reason Bextra sales were discontinued.

Warning labels will also be required on over-the-counter medications containing ingredients like generic ibuprofen, ketoprofen or naproxen, warning consumers about increased heart and bleeding risks, as well as possible allergic reactions. To provide some contrast, the FDA said "NSAID" must be displayed prominently on the label in a different color or in bold type.

A Pfizer spokeswoman said the company is reviewing the agency's letter and would finalize the label with them. In 2004, Pfizer's Celebrex and Bextra generated $4.6 billion in worldwide sales.

For more information on Celebrex, please contact us to confer with a Celebrex Lawyer and learn your legal rights and options.

 

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