WASHINGTON, Oct 06, 2004 (United Press International via COMTEX) -- A study initiated by U.S. regulators says failing to pull Vioxx from the market would have led to more than 27,000 heart attacks and sudden cardiac deaths.
The study of the arthritis drug was initiated by the Food and Drug Administration and partially funded by health maintenance organization Kaiser Permanente, the Wall Street Journal reported Wednesday.
The 27,000 figure compares to how many similar incidents would have occurred had the same patients been taking Celebrex, the Pfizer drug that competed with Vioxx. Those figures don't come from actual counts, but are projections based on findings from an analysis of a database of patients of Kaiser Permanente.
Specifically, the study found that from Vioxx's approval in 1999, through 2003, an estimated 27,785 heart attacks and sudden cardiac deaths "would have been avoided" had Celebrex been used instead of Vioxx.
In providing its potential estimate of the adverse impact, the study is a new headache for Merck and its shareholders, facing a flood of personal injury lawsuits.
The FDA has declined to endorse the study's results, pending further review.
Copyright 2004 by United Press International.