USA's FDA and SAEC complete third data release on drug-induced liver injury and serious skin reaction

24 February 2010

The US Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) have announced the third release of data 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.

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