The FDA rang in the era of personalized medicine with a labeling change on blood thinner warfarin cautioning that patients with either of two genetic variations might respond differently to the drug, which is sold by Bristol-Myers Squibb under the Coumadin brand.
The label change marks the first time FDA has employed gene-specific information in a label for a major drug, said Dr. Larry Lesko, director of the office of clinical pharmacology at CDER. “This means personalized medicine is no longer an abstract concept but has moved into the mainstream, where it is recommended as a factor in a drug used by millions of people every day,” said Lesko in a press call.
The agency cited the change as evidence of progress in its Critical Path Initiative, whereby FDA hopes to hasten the advent of personalized medicine through encouraging the use of biomarkers in diagnosis, treatment and drug development.
Warfarin label change advises on genetic factors
FDA rang in the era of personalized medicine with a labeling change on blood thinner warfarin cautioning that patients with either of two genetic variations might respond differently to the drug, which is sold by BMS under the Coumadin brand.
