FDA Statement on Coronary Drug-Eluting Stents
MedSun: Newsletter #8, October 2006

In a September 14, 2006, update, the Food and Drug Administration (FDA) provided information in response to inquiries regarding the agency’s position on adverse events related to coronary drug-eluting stents. This information presented describes the current FDA position and does not represent new agency policy.

FDA has been monitoring coronary drug-eluting stents closely since they came on the U.S. market in 2003 and 2004, and will continue to do so. Recently released data suggest a small but significant increased risk of stent thrombosis in patients who have drug-eluting stents. Even though stent thrombosis occurs at low rates, FDA is keenly interested in this issue because of the potential for serious harm to patients. While the new data are of interest to FDA and raise important questions, the agency does not have enough information yet to draw conclusions. For example, it is unclear what causes drug-eluting stent thrombosis, how often it occurs, under what circumstances it occurs, and what the risk of occurrence is in a given patient.

To better understand this issue, FDA recently met with the two manufacturers of these products to discuss any information they might have regarding this issue and to get their perspectives. In addition, FDA plans to convene a public panel meeting of outside scientific experts in the near future to assist in a thorough review of all the data and to make recommendations about appropriate actions.

More information on this topic will be available in upcoming issues of MedSun News.

MedSun Newsletters are available at www.fda.gov/cdrh/medsun