Heart database aims to spot drug side effects


More than 200,000 heart tests from patients in prescription drug trials will be collected in a database so scientists can search for clues about potentially dangerous cardiac side effects, U.S. health officials said on Wednesday.

In a partnership with the Duke Clinical Research Institute, the Food and Drug Administration will supply electrocardiograms (ECGs) that companies submit as part of approval applications for new drugs. Patients' personal information will be removed, the FDA said.

Officials said the large amount of information would be far more useful to researchers than the limited data gleaned from a single clinical trial.

The FDA and Duke are creating a consortium of academic and patient groups, non-profit organizations, companies and others to coordinate and support research using the ECGs, which depict electrical activity in the heart.

Heart damage is one of the most dangerous potential side effects from prescription drugs. Signs of an impact on the heart can doom a drug's chances of reaching the market.

Many medicines, for example, prolong the "QT interval," the time it takes the heart to electrically recharge itself. Experts believe long QT intervals can cause abnormal heart rhythms or death, but they are not sure if relatively small extensions of the interval may be tolerable.

"If we can sort that out, we can be of inestimable benefit to everyone because we're going to know what is a bad signal, and what things we don't have to worry about," said Dr. Janet Woodcock, FDA deputy commissioner for operations.

Information from the ECGs also may help researchers tell if certain patients are more likely to experience heart problems from a medicine already on the market, Duke experts and FDA officials said.

One of the first projects will aim to determine if different responses to medicines may explain why women face higher risks of developing abnormal heart beats.