Glaxo, FDA, Vanderbilt to Study Genetic Basis of Long QT Side Effect

NEW YORK, Dec. 17 (GenomeWeb News) - The US Food and Drug Administration, GlaxoSmithKline, and Vanderbilt University will use First Genetic Trust's enTRUST genetic-banking and research technology to conduct a post-marketing study into the genetic basis for drug-induced Long QT.

Long QT is a side effect for many different classes of drugs characterized by risk of developing heart arrhythmias that may, in rare cases, lead to sudden death.

GSK will use FGT's system to recruit Long QT patients electronically through Vanderbilt and a network of referral sites. The company will use collected blood samples and clinical data to study the genetics of the side effect across several classes of drugs.

The FDA will facilitate patient enrollment by sending letters through MedWatch to health professionals who have reported a case of Long QT or Torsades de Pointe, a particularly severe form of the side effect.