Pfizer Criticized for Inadequate Celebrex Safety Data

FDA criticizes Pfizer for inadequate testing of Celebrex

(PRWEB) February 25, 2005 -- Pfizer was criticized by members of a Food and Drug Administration advisory committee for having inadequate long-term safety data on its blockbuster arthritis drug Celebrex.

After Merck recalled its blockbuster and rival COX-2 inhibitor Vioxx from the market last September, the safety of Pfizers COX-2 drugs Celebrex and Bextra were called into question. A Merck sponsored long-term study had discovered an increased risk of heart attacks and strokes in Vioxx users.

The FDA asked the committee if Celebrex and Bextra should stay on the market in response to the Vioxx recall or if risks could be minimized. The future of Celebrex, Bextra and other COX-2 inhibitor drugs not on the market yet are being discussed, and the FDA is expected to respond to the committees recommendations quickly.

Pfizer scientists plan on meeting with FDA officials after the advisory committee meeting to discuss a proposed Celebrex study examining cardiovascular risks, but the FDA committee is critical of Pfizer because of the absence of longer studies and the ethical factors of a long-term study in high-risk patients considering the findings in another study. A three-year National Institutes of Health study found Celebrex patients had a higher risk of heart attacks and strokes than patients on a placebo.

Read more about the warnings of increased heart failure issued by Pfizer here: http://www.onlinelawyersource.com/celebrex/warning.html

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