FDA committee hears complaint on heart drug

<br>BETHESDA, Md. (AP) _ Physicians prescribing the heart drug Cardura should be warned that a study showed it was linked to an increase in stroke and other cardiac problems, witnesses told a federal advisory

Thursday, May 24th 2001, 12:00 am

By: News On 6

BETHESDA, Md. (AP) _ Physicians prescribing the heart drug Cardura should be warned that a study showed it was linked to an increase in stroke and other cardiac problems, witnesses told a federal advisory panel on Thursday.

Many physicians are unaware the drug might be dangerous, Dr. Lawrence R. Krakoff of the Mount Sinai School of Medicine told a Food and Drug Administration Committee.

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

Krakoff was among those speaking at an FDA hearing on a citizen's petition urging that Pfizer Inc., maker of Cardura, be required to issue a warning about the drug and change the way in which it is used.

``There has been massive misinformation and stonewalling by Pfizer,'' said Dr. Sidney M. Wolfe of the Public Citizens' Health Research Group.

A National Institutes of Health study clearly shows that when compared to another cheaper high blood pressure medicine, Cardura was linked to twice the number of strokes and a higher incidence of patients hospitalized for congestive heart failure, witnesses said.

Pfizer representatives disputed the findings. They said their own studies covering more than a decade of Cardura prescriptions show the drug is safe and effective.

``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.

She said that the NIH study compared the use of cardura with a cheaper fluid-elimination drug in a population of patients at high risk of heart failure.

``In a population at low risk, doxazosin can be a very useful drug,'' she said.

Walmsley urged the committee to take no action to change the labeling of Cardura.

An FDA spokesman said the advisory committee will consider scientific studies of the drug and could make a recommendation to change the way the drug is prescribed. The FDA is not required to follow advisory committee recommendations, but often does.

Attorney Salvatore J. 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.

Graziano said the action was prompted by the NIH study last year. Later, 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.

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.''

Pfizer spokeswoman Vanessa McGowan said the company took no action following the NIH study because it was not required to do so by the FDA.

``We believe that Cardura does not cause congestive heart failure and that the label is appropriate,'' McGowan said.

Cardura has been on the market for 10 years and 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; McGowan put the 2000 worldwide figure at $243 million.