Cardura

A 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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