Safety of Celebrex, Bextra questioned by Europeans

Since the recall of Vioxx in September, 2004, and subsequent release of reports pointing out serious adverse side effects of Celebrex and Bextra, drug approval agencies worldwide have been looking at the complete class of Cox-2 drugs to assess if these should be recalled.

In that respect, two agencies are extremely important because their decisions will not only be followed by other agencies, it will impact the two largest markets (United States and European Union) for Cox-2 drugs like Celebrex and Bextra. (Related article: Bextra safety doubted in three major studies)

European Medicines Agency (EMEA) is a decentralized body of the European Union with headquarters in London. It coordinates the evaluation and supervision of medicinal products throughout the European Union. The Food and Drug Administration (FDA) is a similar agency in the United States. (Related article: FDA warns Pfizer on misleading ads for Celebrex and Bextra)

As part of the ongoing review of COX-2 inhibitors, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) held hearings with Pfizer (for celecoxib or Celebrex, parecoxib or Dynastat/Rayzon/Xapit and valdecoxib or Bextra), Merck Sharp & Dohme (for etoricoxib or Arcoxia) and Novartis (for lumiracoxib or Prexige) on 18 January 2005.

Further to its assessment of data submitted on celecoxib, the Committee requested further clarifications and analyses, in particular of data from the Adenoma Prevention with Celecoxib (APC) and Prevention of Spontaneous Adenoma Polyps (PreSAP) studies. (Related article: Pfizer announces recall risks for Celebrex and Bextra)

The review includes Onsenal (celecoxib), which is used in the orphan (rare) indication in the treatment of adenomatous intestinal polyps in familial adenomatous polyposis. This is a similar treatment area as looked at in the APC and PreSAP celecoxib studies and also the APPROVe study that led to the withdrawal of Vioxx (rofecoxib). Following discussions with the Committee, Pfizer has agreed not to launch Onsenal in the European Union pending finalization of the assessment.

Data on other COX-2 inhibitors (etoricoxib, lumiracoxib, parecoxib and valdecoxib) are currently being assessed. The CHMP will continue its discussions on the review at its next meeting on 14-17 February 2005. The FDA will be conduct a series of public hearings on the Cox-2 drugs from 16-18 February.

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