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Off-label use of stents investigated
A federal committee is investigating the off label use of drug-coated heart stents by U.S. doctors, The Wall Street Journal reported Tuesday.
The U.S. House Committee on Oversight and Government reform has asked Boston Scientific and Johnson & Johnson, makers of the stents to submit marketing materials and clinical data for review.
About 60 percent of drug-coated stents, used to open clogged arteries, are prescribed outside of U.S. Food and Drug Administration boundaries, the Journal said.
Stents are commonly given to patients who have had heart attacks, despite a lack of rigorous testing in such patients, the report said.
While doctors are allowed to prescribe stents to off-label patients, "manufacturers can't encourage off-label use," the Journal said.
Copyright 2007 by United Press International
About 60 percent of drug-coated stents, used to open clogged arteries, are prescribed outside of U.S. Food and Drug Administration boundaries, the Journal said.
Stents are commonly given to patients who have had heart attacks, despite a lack of rigorous testing in such patients, the report said.
While doctors are allowed to prescribe stents to off-label patients, "manufacturers can't encourage off-label use," the Journal said.
Copyright 2007 by United Press International
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