Contact us for free information or to start a free case review.
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.
Copyright © 2001 - 2012 Online Lawyer Source
ATTORNEY ADVERTISEMENT—Thank you for your visit. The content published on this website was not written by medical professionals and should not, at any point, be mistaken for medical advice. Furthermore, the information on this site is intended for educational purposes only and should never interfere with a patient/site visitor and his or her healthcare provider. In addition, viewing the content on this website, requesting additional information, or transmitting information through a contact form should never be considered the formation of an attorney-client relationship. The material published on this site is general and may not apply to your specific circumstances. Every case comes with its own set of unique circumstances; past success discussed on this site does not guarantee future performance. Information found on this website should not be used as incentive to act without seeking counsel from a professional. For more information, please read our disclaimer.