FDA Announcement on Heparin Potency

Dear ACCP Member:

Effective October 1, 2009, the FDA revised the USP unit for unfractionated heparin with the goal of improving the consistency and quality of heparin and bringing it into line with existing international standards. Since the potency was expected to be reduced by approximately 10%, the American College of Chest Physicians (ACCP) convened a taskforce of US, Canadian, and European experts in parenteral anticoagulants and thrombosis to discuss this issue and whether it would impact the implementation of the ACCP antithrombotic and thrombolytic guidelines.

Based on the deliberations of this taskforce, it was decided that the ACCP antithrombotic guideline recommendations would not be revised, but the FDA was requested to collect and assess additional data over subsequent months. Those data have now been evaluated and have confirmed previous findings, and the FDA has posted a notice at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm207506.htm

Sincerely,

Mark Crowther, MD, MSc
Professor And Chair - Hematology And Thromboembolism
McMaster University
Vice-Chair, Thrombosis
Antithrombotic Therapy and Prevention of Thrombosis: ACCP Evidence-Based Clinical Practice Guidelines--9th Edition