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Whistle Blower Warns of Additional Vioxx Risks


In February, 2005, Dr. David Graham, a Food and Drug Administration whistle blower, testified before a three-day meeting of Food and Drug Administration advisors regarding additional potential risks of the painkiller Vioxx.

During the panel discussion, Dr. Graham indicated studies show a range of increased heart attack, which translates to as few as 400 or as many as 10,800 additional heart attacks in men between the ages of 65 to 74, who use Vioxx. Dr. David Graham testified the increased risk occurs even with low doses of the drug.

Merck and Co., the manufacturer of Vioxx, pulled the painkiller off the market on September 30, 2004. The withdrawal from the market of Vioxx occurred after a long-term study indicated an increased risk of heart attacks and stroke.

Graham testified, the typical user of Vioxx is someone in their 60’s, and users are not only limited to men. Graham discerned that persons taking Vioxx already have a one-in-50 risk of heart attack.

Dr. Graham informed the FDA he believes there is also a risk in taking Celebrex at high doses, but at the time of the hearing he did not have sufficient information to make an opinion with respect to use of Bextra. An official of Merck, during the February 17, 2005, FDA hearing, stated the problem appears to affect the whole class of drugs, which includes Vioxx, Celebrex and Bextra.

Tens of thousands of people have filed lawsuits against Merck and Co. arising out of use of Vioxx. In late January, 2005, a panel of federal judges met to consider consolidating the cases. The addressed concern is whether the panel of seven federal judges will be able to consolidate the literal at least 1,400 plaintiff groups and at least 575 lawsuits. The overwhelming majority of lawsuits allege Vioxx caused medical problems such as heart attacks, strokes, kidney damage and gastrointestinal bleeding.

The dangers of Vioxx, some allege, have been hidden by Merck. Insider e-mails published by the Wall Street Journal reveal Merck was fully aware of the health risk of its COX-II inhibitor anti-inflammatory drug as early as March, 2000.

In late December, 2004, a Vioxx class action lawsuit was filed in Arizona. It was filed after studies indicated patients taking the arthritis painkiller for 18 months or longer doubled the risk of heart attack and stroke. Lawsuits like this are on the rise.

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