Fresenius Kabi Responds to a Potential Shortage of Heparin Sodium

July 9, 2019

To our U.S. customers,

We’ve been working closely with the U.S. Food and Drug Administration, ASHP Drug Shortage and our raw material suppliers to help respond to, and mitigate, a potential shortage of Heparin Sodium in the United States.  The potential shortage stems from supply interruptions at other finished-dose manufacturers as well as an outbreak of swine fever in China, which is a major global supplier of the active pharmaceutical ingredient (API) in Heparin (Heparin is derived from porcine intestinal mucosa).

At Fresenius Kabi, we do not rely solely on China for API.  We source from multiple suppliers and geographies to serve our customers, but the situation in China is expected to cause API supply constraints globally for an unknown period.

As mentioned above, the market is also experiencing finished product supply interruptions from other manufacturers. This has significantly increased demand for Fresenius Kabi Heparin. As a leader in injectable medications and a leading supplier of Heparin, Fresenius Kabi has put plans in place to monitor the market and to help mitigate a potential future Heparin shortage.

We understand the significance of Heparin to patient care and are committed to solutions that support you and your patients. We have met increased demand to date, and to maintain long-term supply continuity, we have begun limiting shipments of our Heparin presentations based on historical demand. Please see Tables 1-3 below for a full list of our current Heparin product offerings.

We will continue to work closely with our customers, suppliers, ASHP Drug Shortage and the FDA to assess and respond appropriately to evolving market dynamics. 

For clinical questions, please contact Fresenius Kabi USA Medical Affairs at 1-800-551-7176, Monday-Friday between 8 a.m. and 5 p.m. (CST) or email medinfo.USA@fresenius-kabi.com.  For product-availability updates, please visit our web site at www.fresenius-kabi.com/us/pharmaceutical-product-availability, or call our Customer Service team at 1-888-386-1300.

For updates on global Heparin supply, please see FDA’s web site at https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
 

Sincerely,

Dennis Preusker

Senior Director, Marketing

 

NOTE: Allocation is based on historical usage.