FDA, Duke to Probe Drugs’ Heart Risk

The U.S. Food and Drug Administration said Wednesday it has joined with Duke University to create tools to identify products’ heart risk.

Part of the agency’s Critical Path Initiative with Duke Clinical Research Institute, the effort will tap into a virtual electronic database of more than 200,000 electrocardiograms (ECGs) compiled by the FDA to flag as early as possible cardiac risks associated with new drugs and medical devices that the agency approves for market.

For years, we have received generally low-quality copies of ECGs on paper, and we were limited in our ability to use the information to understand why some treatments affected a patient’s heart, said Andrew von Eschenbach, the FDA’s acting commissioner. Through the development of digital ECG data standards in 2004, the development of the ECG warehouse in 2005, and this partnership in 2006, we are now able to identify biological measures that will help to predict which patients are at an increased risk for cardiovascular side effects. This will ultimately lead to the development of safer and more effective treatments.

The partnership will also use input from a consortium of academia, patient advocacy groups, government and non-profit groups and industry to support research projects involving ECGs obtained in clinical trials.

According to the FDA, women are at higher risk of arrhythmia — or abnormal heart beat — but it is unclear whether this increased risk is linked to differing responses to drugs, a question that will be among the first the effort will take on.