Safety of Drug-Coated Stents Up for Debate

December 2006

Despite two manufacturers of drug-coated stents claiming the benefits of their devices outweigh the risks, the Food and Drug Administration (FDA) believes they pose a risk of death and raise other safety concerns. Clotting risks and patient precautions associated with drug-coated stents are among the topics planned for discussion at the FDA's meeting with Boston Scientific, Johnson & Johnson, and an outside panel of medical experts.

The tiny wire-mesh tubes, coated with drugs, are linked to a higher risk of clotting, or thrombosis, compared with bare-metal stents. The FDA also believes the drug-coated stents may be linked to an increased risk of heart attacks and death, and studies suggest there is an increased risk of clotting, heart attacks and death associated with patients stopping therapy with anti-clotting drugs too early.

Boston Scientific admits there is a slight increase in clotting with their Taxus drug-coated stent, but has seen no increase in heart attacks or deaths. Johnson & Johnson has seen no difference in their Cypher drug-coated stent compared to their bare metal versions.

The FDA is asking an outside panel of medical experts to assess the risks and provide the agency with their recommendations, such as updating the labels with new warnings or changing guidelines on how long people should take anti-clotting drugs. The FDA also wants recommendations for research on the drug-coated stents on the market or awaiting approval.

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