American Society of Hematology

Hematologic Drug Shortage Information


Updated on: February 23, 2018

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

National Shortage of Etoposide Injection

ASH members have reported concern about the national shortage of Etoposide Injection. The Society has been in touch with the FDA’s drug shortage office regarding the critical nature of this shortage. The FDA’s drug shortage office assured ASH that they are working directly with the manufacturers to resolve the shortage.  They noted that two of three manufacturers, including Accord and Fresenius Kabi, have recently released some product. The FDA also noted that all three manufacturers are planning to release additional product throughout March, and the Agency is hoping for a resolution of the situation by April.  Please contact Katherine Stark if you are dealing with a critical case that requires this therapy, and she will connect you with the appropriate FDA staff to help identify an emergency supply.

 

FDA Working to Address IV Saline Shortage Stemming from Puerto Rico Storms
On January 4, the Food and Drug Administration (FDA) posted a statement on its website regarding the IV saline products shortage, which was exacerbated by Hurricane Maria. The Agency had been closely working with one supplier, Baxter, to help it restore production operations in their Puerto Rico facilities. Baxter recently announced that all its facilities on the island have returned to the commercial power grid. The FDA also approved IV solution products from Fresenius Kabi and Laboratorios Grifols to mitigate the shortage, and both of those companies have been working to increase production of saline products. 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.

 

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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