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SAEC Releases Genetic Data Related to Drug-Induced Liver Injury, Serious Skin Reactions

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By Turna Ray

The International Serious Adverse Events Consortium this week released genetic data on drug-induced liver injury and serious skin reactions, its third data release since the public-private collaboration launched three years ago.

SAEC is a non-profit consortium formed in October 2007 between industry, academia, the Wellcome Trust, and the US Food and Drug Administration to identify genetic variants associated with serious adverse events [see PGx Reporter 06-03-2009].

The new data, relating to 368 cases of drug-induced liver injury and 15 cases of serious skin reactions, expand on data that SAEC released in December 2008 and May 2009.

“FDA is pleased with the Consortium's progress,” ShaAvhree Buckman, director of the Office of Translational Sciences in the FDA’s Center for Drug Evaluation and Research, said in a statement announcing the data release. “The continued accumulation of scientific information on the genetic basis of adverse drug events provides researchers with invaluable tools for understanding why some people respond to medicines differently than others."

Researchers who enter into a data use agreement with the SAEC can obtain free access to the newly released data from the non-profit's website, generate custom data inquiries, and receive immediate results.

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