Regulatory Science Update: FDA and International Serious Adverse Events Consortium (SAEC) Complete Third Data Release

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February 21, 2010 – In the field of pharmaco- and toxicogenetics of serious adverse drug reactions (sADRs) in humans, we learn today from a press release by the US Food and Drug Administration (FDA) of the completion and release by the FDA and the International Serious Adverse Events Consortium (SAEC) of the third data set with  focus on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).

The data focus on the genetics associated with DILI and SSR and may help researchers to better predict an individual’s risk of developing these serious complications.

Drug induced liver injury occurs in a small subset of patients and is often associated with a drug that is an unpredictable liver toxin, and may be the cause of acute liver failure in some patients. Although the exact mechanism behind drug-induced liver injury is unknown, research suggests that a person’s genes contribute to their likelihood of developing this injury.

Drug-induced SSRs, such as Stevens-Johnson, present as allergic-like skin reactions (blistering and peeling of the skin) and are considered serious enough to discontinue treatment with the medication. These reactions can be fatal if the signs and symptoms are not quickly recognized.

The released research data relating to drug-induced liver injury (368 cases) and serious skin reactions (15 cases), complement the already released data from the SAEC’s December, 2008 and May, 2009 data releases.

“FDA is pleased with the Consortium’s progress,” said ShaAvhree Buckman, M.D., Ph.D., director of the Office of Translational Sciences in the FDA’s Center for Drug Evaluation and Research. “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.”

The SAEC is a nonprofit partnership of 10 international pharmaceutical companies, the Wellcome Trust, and academic institutions focused on research relating to the genetics of drug-induced serious adverse events.

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

For more information on the International Serious Adverse Event Consortium (SAEC), go to http://www.saeconsortium.org

Information on previous SAEC data releases, follow the links below:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm109077.htm, or
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm163067.htm

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About the Author
thassodotcom Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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