FDA announced in September that it would launch an effort to better understand the potential safety risks of drug-eluting stents. The announcement followed two studies that indicated that patients with drug-eluting stents are at increased risk for heart attack or death as a result of blood clots. The increased risk is considered small but significant.
FDA said it does not have the data needed to properly evaluate these findings. It will convene a panel of outside experts to assist in a thorough review of all available data. It has also met with Johnson & Johnson and Boston Scientific, makers of the two FDA-approved drug-eluting stents, to discuss relevant information they may have. Executives from both companies have made public presentations in recent months showing documentation that their products are safe.
The effort could result in labeling changes, ordering of more clinical studies, or other measures. But for now, the agency believes that J&J's Cypher and Boston Scientific's Taxus are safe and effective when used for approved indications.
The cause of the increased clotting risk has not been determined conclusively. Some believe it might be from the polymers that elute the drug from the stent. There has also been discussion that the problems could be related to improper dosage regimes of Plavix, an anticlotting drug given to patients with stents. FDA's full statement on the matter can be seen at www.fda.gov/cdrh/news/091406.html.