Health News
FDA may withhold public information
Sep 12, 2005, 15:05 GMT
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WASHINGTON, DC, United States (UPI) -- Months before the government issued a safety alert about Guidant Corp. heart devices it had reportedly learned some of the units were short-circuiting.
But records obtained by The New York Times indicate the Federal Food and Drug Administration didn`t make the data public since it treats such information as confidential, the Times said.
Guidant submitted a company report to the FDA in February, revealing its widely used defibrillator, the Ventak Prizm 2 DR, was short-circuiting at the rate of about one a month., the newspaper said. A month later, a college student using one of the implanted units died of sudden cardiac arrest.
In June, the FDA issued an alert about the device, subsequently updating it to say units posed a significant risk.
Defibrillators produce strong electric impulses to halt potentially fatal erratic heart rhythms.
Guidant, which knew about the model`s flaw for three years, did not tell physicians about it until May. The Times disclosure that the FDA also had data that might have alerted doctors is likely to increase scrutiny of the agency`s policies regarding the release of information.
Copyright 2005 by United Press International
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