FDA Updates Warfarin Label to Encourage Genetic Testing

August 23, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration approved updated labeling for “Coumadin,” a common blood-thinning drug, that explains that patients’ genetic composition may influence their response to the drug.

Rockville, MD (Aug. 16)-The US Food and Drug Administration approved updated labeling for “Coumadin,” a common blood-thinning drug, that explains that patients’ genetic composition may influence their response to the drug. The agency directed manufacturers of warfarin, the generic version of Coumadin, to add similar information to their products’ labeling.

The labeling change encourages healthcare providers to use genetic tests before prescribing warfarin. The agency believes the tests would help physicians better determine the reasonable warfarin dose for individual patients, optimize the use of warfarin, and lower the risk of bleeding complications from the drug. The labeling changes result from an analysis of recent studies that found that certain genetic variations influence the way people respond to the drug.

“Today’s approved labeling change is one step in our commitment to personalized medicine. By using modern science to get the right drug in the right dose for the right patient, FDA will further enhance the safety and effectiveness of the medicines Americans depend on,” FDA Commissioner Andrew C. von Eschenbach said in an agency press release. The agency’s personalized medicine initiative is based on pharmacogenomics, the science that predicts a response to drugs based upon a person’s genetic makeup.

FDA’s

CriticalPath Initiative

funded a research project and urged a clinical trial to study warfarin dosing based on genetic test information. The specific dose recommendations are described in the warfarin product labeling, along with the new information about the influence of genetic information on the initial dose and the patient’s response to warfarin.