Pfizer highlights risks of recall of Celebrex, Bextra

Since the recall of Vioxx in September 2004, there has been a lot of concern among physicians and patients about the safety of Cox-2 class of drugs. Dr. Eric Topol, renowned cardiologist and an early critic of Vioxx, writing in the Journal of American Medical Association (JAMA) says, "...there are major concerns about how an entire drug class has gone awry with respect to unleashing significant cardiovascular hazard. A "house of cards" is defined as a flimsy situation that is in danger of collapsing or failing. From the outset, the coxib class of medicines seemed destined for potential collapse. This is so poignantly clear for an indication such as arthritis, which is one of the most common conditions requiring medication."

Responding to the concerns and recognizing that there are as many as 139,000 casualties from Vioxx alone, FDA is reviewing the whole Cox-2 class at its meeting next month. Agencies in other parts of the world are not only doing their own reviews, they are also looking at the hearings by the FDA. Whatever the FDA does will have a serious impact on what other agencies do. Most experts agree that if FDA recommends that Celebrex and/or Bextra be recalled, then other agencies will simply follow suit. (Related article: Vioxx recall makes drug agencies worldwide more careful)

This has raised a lot of concern among Pfizer shareholders. According to latest financial statistics released by Pfizer, Celebrex ($3.3 billion) and Bextra ($1.3 billion) together accounted for $4.6 billion in sales or approximately 10% of its overall sales. In other words, if the FDA does anything to jeopardize this revenue stream and the resulting class action lawsuits from Celebrex and Bextra patients will cripple Pfizer. Pfizer addressed the concerns of its shareholders in a statement released today:

"In light of recently released cardiovascular-safety data from several long-term trials in non-arthritis and non-pain indications and other information about COX-2-specific inhibitors and a non-selective non-steroidal anti-inflammatory drug, the FDA announced that it will analyze the available information on these medicines (including Celebrex and Bextra) to determine whether additional regulatory action is appropriate.

The FDA Advisory Committee meeting will take place February 16-18. We will be participating in the Advisory Committee meeting, and we look forward to a reasoned scientific discussion in which we will provide data in support of our belief that Celebrex and Bextra present a cardiovascular risk profile comparable to that of non-selective non-steroidal anti-inflammatory drugs and are important therapeutic options. (Related article: Pfizer provides safety update on Celebrex and Bextra)

Of course, we do not know what the Advisory Committee will recommend to the FDA, what actions the FDA may take after receiving those recommendations, or the timing of these events. If the FDA were to take actions that result in a significant loss of sales of Celebrex and/or Bextra, this could have a material adverse impact on our results of operations, the timing of which would depend upon the period to which any such action was attributed."

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