FDA, researchers focus on genetics of drug hypersensitivity

Abstract

Drug hypersensitivity reactions are gaining the interest of researchers and regulators, in part because of increased knowledge about the genetic underpinnings of these adverse drug events. “Recently, we’ve learned that a number of [reactions] have been associated with certain genetic markers,” said Lynne F. Sylvia, clinical pharmacy specialist at Tufts Medical Center in Boston. “We’ve always suspected that there was a genetic predisposition to allergies. But it’s only in the last 10 or 15 years where we’ve had the ability, through technology and through focus on gene therapy, to really do the studies to identify whether the genetic predisposition exists.” Researchers have shown that people who carry the human leukocyte antigen (HLA) B*5701 allele are at high risk for a potentially deadly multiorgan hypersensitivity reaction to the antiretroviral drug abacavir. Labeling for the drug recommends that all patients be screened for the presence of the allele before starting therapy with abacavir, and FDA advises against the use of the drug in those who test positive for HLA-B*5701.