Celebrex Safety News

Contact a Celebrex Lawyer

or

February 25th, 2005

"COX-2 safety questions far from answered"

A three-day FDA Advisory Committee meeting has wrapped, but the COX-2 drugs controversy is still not resolved. Although the panel of government medical experts advised keeping the drugs, including Pfizer Inc.’s Celebrex and Bextra, on the market, new warning labels were recommended that could include the strongest FDA required “black box” warning.

The new safety labels would warn patients of evidence that COX-2 drugs raise patients’ risks of heart attacks, strokes and other cardiovascular events. Both doctors and patients are hoping that the new warning labels that will probably be written in the next several weeks will use simple and direct language identifying the most at- risk patients.

Pfizer officials responded to the recommendations saying they were pleased overall with the outcome but there would be dialogue between the FDA and the company. The president of Pfizer Global Research & Development said by the end of March more information about the warning label would be decided. Until Pfizer finishes its labeling negotiations with the FDA, the company said it is not planning on putting an interim warning on Celebrex or Bextra.

The FDA is reviewing the panel’s recommendations, which they are expected to agree with. After company regulatory experts begin writing new labels based on FDA specifications, which could begin as early as next week, several weeks of closed-door negotiations between the FDA and the pharmaceutical companies over specific wording will occur.

In the meantime, doctors and patients continue to be unsure about if they can take Celebrex safely. The American College of Rheumatology responded by devoting a section of its Web site to including patient information about COX-2 drugs, and the group said it is going to start a hotline in March to answer questions about COX-2 drugs and other anti-inflammatories.