How to Evaluate the Risk of Torsades Within Drug Development Programs?
By Linda J. Little PHOENIX, AZ — October 8, 2004 — New understanding of drug-induced Torsades de Pointes, a potentially lethal arrhythmia, may aide in detecting the risk before a drug comes to market, according to a medical lecturer and researchers speaking here on October 5th at the at the 33rd Annual American College of Clinical Pharmacology. The scare of deadly arrhythmias — which resulted in Seldane (terfenadine) being pulled from the market in 1997 — has prompted regulatory agencies and researchers to look more closely at the effect of new drugs on the heart before allowing them on the market. “The standards for testing for arrythmias today greatly have improved,” said Robert R. Fenichel, MD, PhD, Lecturer, Department of Medicine, Georgetown University Medical School, Washington DC, said in an interview. Dr. Fenichel discussed the outcomes of an independent academic task force on drug-induced changes in heart rhythm (J Cardiovasc Electrophysiol. April 2004.15:475-495). He said
