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Angie Drakulich was editorial director of Pharmaceutical Technology.
The International Serious Adverse Event Consortium (SAEC), a nonprofit partnership, has helped the US Food and Drug Administration gain significant understanding of the genetic basis for drug-induced liver injury, according a new FDA press release.
The International Serious Adverse Event Consortium (SAEC), a nonprofit partnership, has helped the US Food and Drug Administration gain significant understanding of the genetic basis for drug-induced liver injury (DILI), according an FDA press release. The SAEC collaboration, which includes 10 international pharmaceutical companies, the Wellcome Trust, and academic institutions, was launched in August 2007 to focus on research relating to the genetics of drug-induced serious adverse events.
The consortium has identified a genetic link-specifically, the HLA-B*5701 genotype-associated with liver injury in some individuals who take the antibiotic flucloxacillin. "These findings provide the research community with novel genomic data on DILI events and make an important contribution to the science of drug safety," said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in the release. "By making these data available, the research community will have better tools to evaluate predictive biomarkers for adverse events such as DILI.”
In related news, FDA recently issued a final rule regarding warnings and risk information for pain relievers such as acetaminophen because of the risk for liver damage. An FDA advisory committee is meeting to further discuss this topic at a June 29–30 meeting.