FDA and SAEC Release First Data on Genetic Basis of ADEs

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Updated October 27, 2022

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FDA And International Serious Adverse Events Consortium Release First Data On Genetic Basis Of Adverse Drug Events - Pharmaceutical Online

---  the original post follows below  ---

The FDA just announced, FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of 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 today by the FDA 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. “We are pleased to be able to provide these invaluable data to the research community to both 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,” said Arthur Holden, founder and chairman of the SAEC. This is a pretty exciting example of how to apply genomics to research the genetic basis of serious adverse events. 

Additional Information: 

• For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org. 
• For information on the FDA’s Critical Path Initiative see http://www.fda.gov/oc/initiatives/criticalpath/ 

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