American Society of Hematology

Hematologic Drug Shortage Information


Updated on: November 20, 2017

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

FDA Working to Address Drug Shortages Stemming from Puerto Rico Storms

On October 13, the Food and Drug Administration (FDA) posted a statement on its website stating the Agency prevented a significant shortfall of Baxter's sodium chloride injection bags by facilitating the importation of the products from company facilities in Ireland and Australia. The shortfall was due to lost manufacturing days at the company's Puerto Rico facility. The FDA also is expediting reviews and approvals of other dosage forms and generic versions of products as alternate sources.  Note that any additional shortages can be tracked on FDA’s drug shortage page.  ASH continues to monitor shortages impacted by the storms and ASH members in the affected areas should contact the Society (kstark@hematology.org) if they are encountering issues accessing critical therapies.

 

Discontinuation of DepoCyt

Pacira Pharmaceuticals, Inc. has disclosed that they will discontinue all future manufacturing and supply of DepoCyt (Cytarabine liposome injection). At the current rate of distribution the stock of DepoCyt will be depleted by August 2017. DepoCyt was used in the treatment of lymphomatous and leukemic meningitis. The reason for the discontinuation of DepoCyt is due to manufacturing challenges and there are no plans to resume manufacturing. Please refer to the FDA shortage website for up to date information. ASH will continue to monitor this shortage and provide members with real-time updates.

 

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.  

(As of August 2017 the FDA reports that Erwinaze is still in shortage. There is availability expected the week of September 4, 2017. As of October 2017, Erwinaze is back on the FDA Shortage List.)

 

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. 

(As of August 2017 the FDA reports that there are still recalls of Kogenate FS and Helixate FS)

 

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

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Current Hematologic Drug Shortages

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Recently Resolved Hematologic Drug Shortages

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Additional Resources

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

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Media Coverage of Drug Shortages

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