May 24, 2001 - F.D.A. Panel Considers Warning Label for a Heart Medicine

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An FDA advisory panel at the request of a NY law firm, have recommended that Pfizer, change the label of its heart drug Cardura. The recommendation comes after a trial investigation conducted last year determined that Cardura was not as effective as previous medicines used in treating certain types of heart diseases. The trial also found that patients taking Cardura with high blood pressure were two times as likely to be hospitalized for congestive heart failure than if they took an older drug.

"The committee concluded that something should be communicated to physicians so they know the results of this trial," said Dr. Jeffery Border, the FDA advisory panel chairman. The NY law firm that pushed for the label change believes Pfizer was aware of the unsupported effectiveness of Cardura, but purposefully kept the information quiet. Pfizer, however, believes that a label change is unwarranted.

Mariann Capriano, a Pfizer spokeswoman, said the company has sponsored 316 clinical trials to study Cardura and it has been unable to find a link between the drug and congestive heart failure. Others still disagree.

"Pfizer's delay in providing notification may have caused thousands of unnecessary cases of heart failure among the large number of hypertensive patients who currently use Cardura, " said Dr. Curt D. Furberg, chairman of the steering committee of the government study.

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