Cardura safety mulled by FDA panel

A US Food and Drug Administration advisory panel has concluded thatphysicians should be made aware of the results of the ALLHAT study, which found that patients taking Pfizer's alpha blocker Cardura (doxazosin mesylate) were more likely to be hospitalized for heart failure or suffer a cardiovascular event than those treated with a comparator drug, the diuretic chlorthalidone.

However, the panel was unable to agree on the best way of describing the findings or of disseminating them, bowing to the FDA to decide how to proceed with the matter. They suggested that the agency gather more data on the drug before making alterations to Cardura's labeling, according to a Reuters report. Specifically, the panel voted against a petition requesting that a black box warning be added to the prescribing information for the drug.

Last June, patients treated with Cardura filed a class action lawsuit against Pfizer, claiming that the firm had failed to warn them of serious risks related to the drug (Marketletter June 12, 2000). The plaintiff's legal representation alleges that Pfizer mounted a campaign to minimize publicity of the ALLHAT results.