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FDA Refuses to Approve Pfizer Cox-2 Drug

April 8, 2005
The Food and Drug Administration has refused to approve a liquid Cox-2 painkiller application submitted by Pfizer. The FDA did not cite its reasons for issuing the "non-approval" letter for Pfizer's parecoxib sodium, marketed in Europe and elsewhere Dynastat.

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Pfizer said it plans to appeal the rejection. It argues that Dynastat reduces the need for opioids to control pain after surgical procedures. The company noted that European regulators had found that the Cox-2 class of drugs provided benefits that outweigh their risks.

Merck pulled its Cox-2 drug, Vioxx, off the market in September 2004, saying it was "putting patient safety first" but the Wall Street Journal reported earlier that company officials had fought for years to protect the highly profitable drug and to keep news of the health risks quiet.

The FDA estimates that Vioxx may have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. The estimate is based on the number of prescriptions issued for Vioxx between 1999 and 2003.

In August, a Texas jury awarded the widow of a Vioxx user who died from a heart arrhythmia $253.4 million. The second of what is likely to be many Vioxx-related trials got underway this week in Atlantic City, N.J.

Pfizer's two Cox-2 painkillers, Celebrex and Bextra, have also been linked to higher risks of heart problems.

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