FDA to Hear Heart Drug Complaints
De: Associated Press
The New York Times, May 25, 2001
BETHESDA-- A group of patients is petitioning the federal government to
force Pfizer Inc. to issue a safety warning about Cardura, a cardiac drug
that has been linked to increased heart failure in studies comparing it to
a cheaper medication.
Lawyers representing patients who have taken Cardura were to ask on
Thursday that a Food and Drug Administration advisory committee recommend
``an emergency safety notification'' to patients and that the approved
uses of the heart drug be changed.
The petition also asked that Pfizer be required to include a warning in
the label instructions for 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.
Salvatore J. Graziano, a New York lawyer representing the patients,
said the action was prompted by a National Institutes of Health study last
year that showed patients using Cardura were twice as likely to be
hospitalized for congestive heart failure as were patients using a cheaper
diuretic drug.
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.
Despite these actions, said Graziano, Pfizer has not modified the
recommended uses for Cardura and the FDA has not issued orders affecting
the drug.
``None of the agencies have required Pfizer to take any action,'' said
Graziano.
On behalf of two men who represent a class of patients taking the drug,
Graziano filed suit last year in U.S. District Court for the Southern
District of New York, asking that Pfizer be ordered to send a safety
notice to Cardura patients.
Graziano said that the suit also asks that label instructions for
Cardura be changed so it can no longer be used as a ``first line drug''
for treating heart disease.
Instead, Judge Lawrence M. McKenna instructed Graziano's clients to
seek relief from the FDA.
In January, Graziano filed a citizen's petition with the FDA asking
``an emergency safety notification to persons who are at immediate risk of
death or graver personal injury.''
Vanessa McGowan, a spokeswoman for Pfizer, 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,'' said McGowan. She declined other comment
because, she said, of the lawsuit.
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 claims Pfizer has
worldwide Cardura sales of about $800 million, but McGowan put the 2000
worldwide figure at $243 million.
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