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Are drug-coated stents safe?

Last reviewed: September 2009

It seemed like a breakthrough at first: Adding a drug to the tiny tube that props open a blocked artery after a common heart procedure, which slashes the risk of renewed narrowing and blockage of the blood vessel. Doctors rushed to use the new device, called a drug-eluting stent, which boosted the effectiveness of percutaneous coronary intervention (PCI), or angioplasty, in which a tiny balloon is inserted into a blocked artery. When inflated, the obstruction is pushed against the artery wall, the passageway widens, and blood flows freely.

Then came alarming news: Studies found that the drug might increase the chance of blood clots, a catastrophic complication with a high risk of causing heart attacks and death. In 2006 the Food and Drug Administration called for further study, and the use of these stents plummeted.

Now the pendulum has swung back, and for good reasons. New research has helped calm fears about the safety of the devices and clarified which patients fare better with them rather than the older, less-expensive bare-metal stents, which lack the drug coating. And while you may think a cardiologist will select the right stent for you based strictly on technical factors, you should understand the options clearly and, if time permits, express a preference when either device might work well.

This drug safety alert is made possible through a partnership between Consumer Reports Best Buy Drugs and The Research on Adverse Drug Events and Reports (RADAR) group, a pharmacovigilance group led by Charles Bennett, MD PhD MPP. This is the second in a series of reports based on research by the RADAR group.

These materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

If you think you have experienced an adverse event with this drug or any drug, especially if it is of a serious nature, it is important to 1) tell your doctor immediately and 2) report the event to the Food and Drug Administration via the FDA's MedWatch website at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or by calling 1-800-FDA-1088.

 
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