American Society of Hematology

Important ASH Drug Update: Critical Shortage of Methotrexate

Published on: February 15, 2012

As you are aware, the country is experiencing a severe shortage of Methotrexate. The shortage mainly involves preservative free large vials (1 g/40ml and 1 g lyophilized powder) and has resulted from one of the manufacturers (Bedford/Ben Venue) voluntarily shutting down its facility because of quality issues while the remaining manufacturers have not been able to meet the shortfall. ASH has been working hard to address the shortage, including reporting shortages to the Food & Drug Administration (FDA) and Congress and urging the FDA to take immediate action to identify other manufacturers to meet demand, import supplies from overseas, and establish an emergency supply once there is a release so that supplies can be easily accessed.

This morning the FDA reported that two manufacturers plan additional releases at the end of this week, at the end of February, and continuing into March, which are anticipated to meet all patient needs. Please see the ASH Drug Update page for specific details. While the Society is pleased with this announcement, we realize the shortage is still critical at many sites throughout the country and will continue to work to resolve this serious problem.

If your practice or hospital is out of Methotrexate or almost out of supplies, you need to notify the FDA as soon as possible by contacting drugshortages@fda.hhs.gov and copy skaplan@hematology.org. 

ASH will continue to track this and other drug shortages closely and will notify the membership as soon supplies become available.

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