American Society of Hematology

Hematologic Drug Shortage Information


Updated on: October 13, 2016

ASH continues to work with Congress, federal agencies, and other stakeholders to ensure continued access to safe and effective hematologic drugs.

New Updates on Hematologic Drug Shortages

Current Shortage of Erwinaze

The U.S. Food and Drug Administration (FDA) recently reported to ASH that Jazz Pharmaceuticals depleted their existing inventory of the critical hematologic therapy Erwinaze. The FDA is working with Jazz Pharmaceuticals to release an additional safe supply of the therapy as soon as possible, but does not have an expected release date at this time.  The most recent lot of Erwinaze was released in May and June 2016 with an FDA-approved letter advising providers about the “particulate matter risks,” noting that reconstituted vials should only be given through intramuscular administration.  ASH will continue to monitor this shortage and provide members with real-time updates.  

Bayer recalls Kogenate FS and CSL Behring recalls Helixate FS

Bayer and CSL Behring are initiating a voluntarily recalls of their hemophilia A drugs, Kogenate FS and Helixate FS (antihemophilic factor VIII [recombinant]). These drugs are being recalled because they containing active ingredients manufactured before November 2015. As part of the routine testing, stability data indicate a decline in potency outside of the pre-specified acceptable range for these lots. The material is packaged in 5mL glass vials and comes in a shelf carton. The Companies are asking customers to immediately quarantine inventory of the affected product under their direct control and to contact retail level customers to remove and return any affected inventory. For more information, please contact CSL Behring Medical Information at 1-800-504-5434 or Bayer at 1-800-288-8371. 

 

For more information on the above notices or to notify ASH of other drug recalls or shortages, please contact Katherine Stark at kstark@hematology.org

back to top

Current Hematologic Drug Shortages

back to top

Recently Resolved Hematologic Drug Shortages

back to top

Additional Resources

back to top

ASH's Comments to Congress and the U.S. Food and Drug Administration

back to top

Media Coverage of Drug Shortages

back to top