FDA Boxed Warning: Clopidogrel (Plavix®) Clinical Alert
- Clinical antiplatelet effectiveness is reduced for poor metabolizers of clopidogrel.
- Genetic tests are available to identify poor metabolizers.
- Emerging role of genetic testing in clopidogrel treatment decisions
Read full clinical alert in Circulation
- Editorial: Responding to the Clopidogrel Warning by the US Food and Drug Administration: Real Life Is Complicated by Dan M. Roden, M.D., and Alan R. Shuldiner, M.D.
- Summary Slide (ppt)
- 21 CFR 201.57 - Specific requirements on content and format of labeling for human prescription drugs.
- FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug