Drug
manufacturer Merck institutes a recall
On September 30th, 2004,
drug manufacturer Merck suddenly withdrew its drug Vioxx
(rofecoxib) from the market after continuing reports showed
that patients taking it faced a substantially increased
risk of several dangerous cardiovascular problems, including
heart attack, stroke and congestive heart failure. The company
made the decision following a three-year clinical trial
to determine the drug’s effectiveness in treating colon
cancer.
More than two million Americans
are currently taking Vioxx for arthritis, migraines and
acute menstrual pain. Another 84 million people around the
world have taken Vioxx since its introduction into the market
in 1999.
Early concerns
The first concerns about Vioxx’s safety emerged as early
as 2000, when researchers noted a higher incidence of heart
attack and high blood pressure than in patients taking other
pain relievers. However, apparently ignoring these results,
Merck insisted that Vioxx had a “favorable cardiovascular
safety profile.” In 2001, the FDA warned the company about
its failure to disclose these risks:
“Your minimizing these potential
risks and misrepresenting the safety profile for Vioxx raise
significant public health and safety concerns... [Your]
claim in the press release that Vioxx has a ‘favorable cardiovascular
safety profile,’ is simply incomprehensible… in fact, serious
cardiovascular events were twice as frequent in the VIOXX
treatment group…” – Thomas W. Abrams, FDA Director, Division
of Drug Marketing, Advertising, and Communications, Sept.
2001
Risks associated with taking Vioxx
In 2004, studies conducted by the FDA and other independent
researchers revealed that patients taking Vioxx had an 80%
greater risk of being diagnosed with congestive heart failure
and a 50% greater risk of heart attacks than patients taking
similar anti-inflammatory medications. Studies also revealed
that those taking the maximum dosage of Vioxx experienced
a three-fold increase in their risk of a heart attack.
FDA officials estimate that
Vioxx has been linked to as many as 27 thousand heart attacks
since 1999. Many more may have suffered from other cardiovascular
diseases associated with it. In spite of the mounting evidence
following its debut on the market, Merck continued to spend
hundreds of millions marketing Vioxx to the public — yet
patients taking the drug were not adequately informed of
the dangers associated with it.
“I believe that there should
be a full Congressional review of this case. … Sadly, it
is clear to me that Merck’s commercial interest in [Vioxx]
sales exceeded its concern about the drug’s potential cardiovascular
toxicity.” – Eric J. Topol, M.D., The New England Journal
of Medicine, October 21, 2004
Are you at risk?
If you or a family member have taken Vioxx and:
have been diagnosed with
heart disease, stroke or congestive heart failure that developed
taking Vioxx, or
have suffered a heart attack, and
have no prior history of cardiovascular problems
then contact
us to discuss your potential claim.