A Food and Drug Administration advisory committee late last month noted that doctors should have more information regarding the use of Pfizer's Cardura heart drug, but the committee made no decision on whether the manufacturer should change the drug's label.
The committee met in response to a citizens' petition demanding changes in the labeling and that a warning be sent to users.
Pfizer executives were pleased that the advisory panel affirmed that Cardura (doxazosin mesylate) is safe and effective as currently labeled for its indications of high blood pressure and benign prostatic hyperplasia. Pfizer will continue to work closely with the FDA as additional data from trials become available to determine whether label additions are warranted.
In a trial, preliminary results showed a lower incidence of congestive hearth failure in patients taking a diuretic, a commonly used treatment for CHF, for which Cardura is not indicated.
COPYRIGHT 2001 Lebhar-Friedman, Inc.
COPYRIGHT 2001 Gale Group
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