FDA, International SAE Consortium Release Genetic Data on Adverse Drug Events

The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released recently by the Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual's risk of developing these reactions.

According to FDA, both skin conditions appear as allergic-like skin reactions associated with blistering and peeling, and are considered life-threatening. Medications causing these serious allergic reactions should be discontinued; and, if such signs and symptoms are not quickly recognized, these reactions can be fatal.

"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," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research. "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."

SAEC is a nonprofit partnership of pharmaceutical companies, the Wellcome Trust, and academic institutions focused on research relating to the genetics of drug-induced serious adverse events. The samples from the initial serious skin rash cases and matched controls were collected by GlaxoSmithKline plc, London, U.K., and donated to the consortium for this research.

By pooling these samples, SAEC has identified numerous genetic associations that may contribute to an individual's risk of developing serious drug-induced skin reactions. The data was compiled and analyzed just 16 months after the consortium was launched.

For more information, go to www.saeconsortium.org or www.fda.gov/oc/initiatives/criticalpath.

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