ACCF/AHA Clopidogrel Clinical Alert: Approaches to the FDA “Boxed Warning”

Abstract

Intermediate metabolizers have 1 copy of a loss-of-function allele and may also have decreased active metabolite levels and reduced antiplatelet effects when treated with clopidogrel, but the boxed warning only refers to poor metabolizers. Angiolillo Organizational Reviewer--Society for Cardiovascular Angiography and Interventions Accumetrics Arena Astra-Zeneca Bristol-Myers Squibb* Daiichi Sankyo* Eli Lilly* Merck Novartis Portola Sanofi-Aventis* Bristol-Myers Squibb* Daiichi Sankyo* Eli Lilly* Sanofi-Aventis* None Accumetrics* Astra-Zeneca* Daiichi Sankyo* Eisai* Eli Lilly* GlaxoSmithKline* Johnson & Johnson* Portola* Schering-Plough* The Medicines Company* None None Thomas M. Beaver Organizational Reviewer--Society of Thoracic Surgeons Pfizer None None None None None Doug Campos-Outcalt Official Reviewer--American Association of Family Physicians None None None None None None Donald E. Casey, Jr. Official Reviewer--American College of Physicians None None None None None None Matthew J. Price Organizational Reviewer--Society for Cardiovascular Angiography and Interventions Accumetrics* AstraZeneca Bristol-Myers Squibb/Sanofi-Aventis DSI/Lilly DSI/Lilly None Bristol-Myers Squibb/Sanofi* None None Craig H. Selzman Organizational Reviewer--Society of Thoracic Surgeons None None None None None None Jeffrey L. Anderson Content Reviewer--ACCF UA Guideline None None None None None None Eric R. Bates Content Reviewer--ACCF PCI Guideline Bristol-Myers Squibb Daiichi Sankyo Eli Lilly Momenta Novartis Sanofi-Aventis Takeda None None None None None John G. Byrne Content Reviewer--ACC Surgeon Scientific Council None None None None None None Victor A. Ferrari Content Reviewer--ACCF Task Force on Clinical Expert Consensus Documents None None None None None None Federico Gentile Content Reviewer--ACCF Task Force on Clinical Expert Consensus Documents None None None None None None Jonathan L. Halperin Content Reviewer--ACCF Extracranial and Vertebral Artery Disease Guideline Astellas Bayer Biotronik* Boehringer Ingelheim* Daiichi Sankyo Pharma Johnson & Johnson* Portola Sanofi-Aventis* None None None None None Robert A. Harrington Content Reviewer--ACCF Task Force on Clinical Expert Consensus Documents AstraZeneca* Baxter CSL Behring Eli Lilly Luitpold Merck Novartis Otsuka Maryland Research Institute Regado Schering-Plough* Sanofi-Aventis The Medicines Company None None AstraZeneca Baxter Bristol-Myers Squibb* GlaxoSmithKline* Merck* Portola* Schering-Plough* The Medicines Company None None L. David Hillis Content Reviewer--ACCF CABG Guideline None None None None None None Frederick G. Kushner Content Reviewer--ACCF STEMI Guideline FDA None Bristol-Myers Squibb Pfizer Merck Roche Holding* Daiichi-Sankyo Hoffmann La Roche Novartis None None Gordon F. Tomaselli Content Reviewer--ACCF Proton Pump Inhibitor Expert Consensus Document None None None None None None * This table represents the relevant relationships with industry and other entities that were disclosed at the time of peer review.