An unreleased FDA study cited by the Wall Street Journal indicates that Vioxx may be linked to over 27,000 heart attacks and sudden cardiac deaths. Merck & Co. manufactured the drug which has been prescribed to millions of arthritis and pain sufferers worldwide since its launch in 1999. In response to a Merck study showing that patients taking Vioxx were more likely to suffer a cardiac event than those taking a placebo, the drug manufacturer abruptly pulled the popular drug from the market in late September.

The Wall Street Journal reported that the FDA study found that use of Vioxx might have caused 27,785 heart attacks that could have been avoided by using available prescription alternatives. The FDA and Merck have not issued a response to the Wall Street Journal article. A Merck spokesman has stated that the drug manufacturer could not comment on the study since the company had not yet been given the opportunity to review it. Analysts state that Merck is now confronting the possibility of numerous lawsuits and sizeable liability relating to the Vioxx recall.

WSJ also reported that Senate Finance Committee Chairman Charles Grassley has requested a copy of the study's findings, although the study has not been made public to date. Senator Grassley is heading a Senate committee investigation of the FDA's practices surrounding the agency's handling of safety concerns.

Reports of the FDA findings regarding Vioxx are occurring as growing speculation among scientists and European regulators emerges that other pain relievers may increase the risk of heart attack and stroke. The European Medicines Agency in London has recently released plans to review drugs similar to Vioxx. The New England Journal of Medicine published two reports relating to these issues on its website and plans to publish these works in the near future.

Celebrex, a Pfizer drug with similar attributes to Vioxx, has also fallen under scrutiny due to concerns that it causes similar ailments. Early studies have indicated that the problems associated with Vioxx apply to a class of drugs, a class including Celebrex. Numerous researchers have criticized the FDA for their failure to impose more strict testing requirements on drug manufacturers. FDA officials have previously stated that the heart problems reported were unique to Vioxx. Pfizer's medical director, Dr. Gail Cawkwell, insisted that Celebrex is safe, claiming that the studies on its drug exceeded the data gathered for Vioxx. Publication of a study challenging the safety of the Pfizer drug is planned for an upcoming October issue of New England Journal of Medicine.