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U.S. advisory panel recommended that regulators require changes to the label for
Pfizer Inc.'s blood pressure drug Cardura. U.S. researchers determined last year
that Cardura was less effective than an older medicine for treating certain
types of heart disease.
"The committee concluded that
something should be communicated to physicians so they know the results of this
trial," said Dr. Jeffrey Borer, the panel's acting chairman.
Pfizer Inc.'s Cardura drug is
marketed as a class of blood-pressure medicines known as alpha-blockers.
Researchers said the results of the study suggest the drugs might not be the
best choice as first-line therapy for high blood pressure and patients now using
them as first-line treatment should talk to their doctors about whether to
change therapy.
Last year, a National Institutes of
Health study found that Cardura users had experienced congestive heart failure
more frequently than those who used a cheaper diuretic. The FDA advisory panel
heard a petition from a Cardura user who also has filed suit against Pfizer. The
user sought to compel the FDA and Pfizer to change the drug's labeling and
officially notify users and doctors of the findings from the NIH study.
The lawsuit claims that Pfizer
officials intentionally maneuvered around negative reports on Cardura, because
sales of the drug were approximately $800 million in 2000. Internal Pfizer
documents and e-mail have surfaced demonstrating that company officials were
less than truthful about Cardura while avoiding drawing attention to the NIH
study.
For example, a company e-mail said
that Pfizer decided at one point not to issue a statement on the NIH study --
which Pfizer paid $30 million to help fund -- and a related announcement from
the American College of Cardiology because "a Pfizer-issued statement in
defense of Cardura would likely draw more media attention to the situation. To
date, there has been limited media coverage."
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