Panel Agrees to Cardura Warning for Physicians
An FDA advisory committee has decided that physicians should receive "more information" about the heart drug Cardura, but made no ruling on whether the drug's label should be changed to mention the drug's possible link to congestive heart failure and stroke, the AP/Baltimore Sun reports (AP/Baltimore Sun, 5/25). The advisory committee was convened to consider the petition of two former Cardura users who asked the FDA to issue such warnings on the medication's label. Although a previous study had found that people taking Cardura were twice as likely to be hospitalized for congestive heart failure than people taking a less-costly diuretic, neither the FDA nor Cardura manufacturer Pfizer had alerted physicians or consumers of the link. The patients' petition asked that the FDA require Pfizer to issue a warning about the drug and restrict its use in treating high blood pressure (Recer, AP/Philadelphia Inquirer, 5/25). The panel, however, recommended that the FDA wait to inform doctors until the agency had more information from the study, adding that "they did not think there was enough data to prove that Cardura was harmful." In addition, the committee ruled against informing patients currently taking Cardura of the study's findings, stating that the patients "could misinterpret the information" (Petersen, New York Times, 5/25). However, Salvatore Graziano, an attorney for the patients taking the drug, said he was "content" with the panel's decisions. "By our count, there was an 8-2 vote that there should be some communications about this study. We got what we came for," he said (Recer, AP/Newark Star-Ledger, 5/25).
During the panel hearings yesterday, several doctors said that they "feared" that some patients taking Cardura might not be suitable for the drug. Dr. Franz Messerli of the Ochsner Clinic in New Orleans and a former adviser to the FDA, said that many physicians were unaware of the potential consequences of Cardura because drug firms had painted the drug as "particularly efficacious" in preventing heart disease. He wrote in a statement, "Physicians have been subjected to years of what in retrospect must be considered misinformation" (New York Times, 5/25). Pfizer, however, called the study "flawed" and said that "years of study" have shown Cardura to be "safe and effective." Tricia Walmsley, a medical director at Pfizer, said that "no evidence" exists to link Cardura with congestive heart failure or stroke (AP/Philadelphia Inquirer, 5/25). Graziano's law firm estimated that annual global Cardura sales total about $800 million, although a Pfizer spokesperson said the drug grossed about $243 million in worldwide sales in 2000 (AP/Richmond Times-Dispatch, 5/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.