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FDA, SAEC Release First Data on Adverse Events

NEW YORK (GenomeWeb News) — A collection of new data about the genetics associated with drug-induced serious skin rashes has been released by the US Food and Drug Administration and the International Serious Adverse Events Consortium.

The FDA said yesterday that the release of this genetic data about serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with adverse drug reactions could be used to help predict which individuals will experience them.

The SAEC is a nonprofit that includes pharmaceutical companies, the Wellcome Trust, and academic institutions that study drug-induced reactions. It began its research efforts nearly a year and a half ago.

This release of data on skin rashes is the first made available through the partnership, FDA said. These samples were from serious skin rashes and matched controls that were collected by GlaxoSmithKline in London and donated to the consortium specifically for this research.

Using these samples, the SAEC identified "numerous genetic associations that may contribute to an individual's risk of developing serious drug-induced skin reactions," FDA said.

"The SAEC has fulfilled a key goal of the Critical Path Initiative by providing the research community with public access to new genomic data on adverse drug events," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

"This consortium has taken a significant step forward by promoting open sharing of drug safety data. This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient's risk for experiencing an adverse drug event," she said.

Arthur Holden, who founded and chairs the SAEC, said this release of data is "invaluable" for researchers, and they can use it to "improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events."

Researchers who enter into a data use agreement can obtain access to the data for free in order to generate custom data inquiries and obtain immediate results on the genetic basis of adverse drug events.

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