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FDA committee hears complaint on heart drug

Aug 13, 2001 | AP

A federal advisory committee decided Thursday that physicians need to have more information regarding the use of the heart drug Cardura, but they made no decision on changing the label.

Committee chairman Dr. Jeffrey Borer, a cardiologist at Cornell University in New York, said the consensus of the committee was that more data from a federal study should be communicated to physicians, but "the forum is not defined."

Borer chaired an FDA advisory committee called to hear a citizens' petition demanding that instructions on the label for the heart drug be changed and that a warning be sent out because of a study that linked the drug to congestive heart failure and stroke.

Salvatore J. Graziano, a New York attorney who brought the petition on behalf of patients taking Cardura, said he was content with the action of the committee.

"By our count, there was an 8-2 vote that there should be some communications about this study," he said. "We got what we came for."

Before the committee acted, drug maker Pfizer Inc. defended Cardura before the group, contending that years of study have shown it to be safe and effective.

Company representatives said a federal study that linked Cardura to increases in congestive heart failure and stroke was flawed.

"There is no evidence that doxazosin (Cardura) is causally associated with the occurrence of congestive heart failure, heart attack or stroke," said Tricia Walmsley, a Pfizer medical director.

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.

The FDA is not required to follow advisory committee recommendations, although it usually does.

The citizens' petition was prompted by a National Institutes of Health study that compared Cardura with a cheaper drug in the control of high blood pressure and cholesterol.

Called ALLHAT, for antihypertensive and lipid lowering treatment to prevent heart attacks, the Cardura portion of the study was stopped last year after researchers concluded that patients on the drug were twice as likely to be treated for congestive heart failure or for stroke.

The American College of Cardiology issued a clinical alert advising physicians to stop prescribing Cardura or to reassess its use for treatment of high blood pressure. Neither Pfizer nor the FDA took any action.

Graziano filed suit last year in U.S. District Court for the Southern District of New York on behalf of two men who represent a class of patients taking the drug.

The lawsuit asks that Pfizer be ordered to send a safety notice to Cardura patients and that label instructions for Cardura be changed so it can no longer be used as a "first line drug" for treating heart disease.

Judge Lawrence M. McKenna instructed Graziano's clients to seek relief from the FDA.

In January, Graziano filed a citizen's petition with the agency seeking "an emergency safety notification to persons who are at immediate risk of death or graver personal injury."

Many physicians are unaware the drug might be dangerous, Dr. Lawrence R. Krakoff of the Mount Sinai School of Medicine, speaking for the petitioners, told the FDA committee.

"There must be a warning," he said. "This is a safety issue."

Another witness, Dr. Sidney M. Wolfe of the Public Citizens' Health Research Group, accused Pfizer of "massive misinformation and stonewalling."

Wolfe said Pfizer representatives continued to press doctors to prescribe Cardura, making "scripted" sales presentations "devoid of science and medical ethics."

Walmsley told the committee the ALLHAT study's design distorted the effect of Cardura. A review of other studies using Cardura, a drug on the market since 1990, show it does not harm heart patients, she said.

If the drug was as dangerous as ALLHAT suggested, there should be risk signals in the more than one dozen other studies using Cardura, Walmsley said.

"We did not see any evidence of adverse effects in our studies," she said.

Gretchen Dieck, another Pfizer representative, said there have been more than 4 billion patient days of use for Cardura. Repeated safety studies show incidents of heart attack and stroke among those patients "was consistent" with other drugs used to lower blood pressure, she said.

Cardura is among the top 50 prescriptions filled in the U.S. Graziano's law firm says Pfizer has worldwide Cardura sales of about $800 million; Vanessa McGowan, a spokeswoman for Pfizer, put the 2000 worldwide figure at $243 million.

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