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
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.