Warfarin label change advises on genetic factors

Share this article:
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.

Share this article:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.