US Pharm. 2009;34(3)(Oncology suppl):14.The FDA and the International Serious Adverse Event Consortium (SAEC) have identified numerous genetic associations that may contribute to an individual's risk of developing serious drug-induced skin reactions. The data, which were compiled and analyzed in just 16 months after the consortium's launch, focus on the genetic link associated with drug-induced serious and life-threatening skin rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis. The SAEC will publish the initial research results later this year.
"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, MD, director of the FDA's Center for Drug Evaluation and Research.