The U.S. Food and Drug Administration will permit the importation of sterile saline solution from an Australian company to help deal with an ongoing shortage in both veterinary and human medicine.
The announcement, reported today by the American Veterinary Medical Association, should benefit large animal veterinarians because 3- and 5-liter bags of intravenous fluids are particularly hard to find.
“Today’s announcement comes at a time when large-volume parenteral fluid shortages have become critical in equine medicine,” wrote AVMA@Work blogger Lynne White-Shim, DVM, MS, the assistant director of AVMA’s Scientific Activities Division.
“In collaboration with the American Association of Equine Practitioners, the AVMA shared members’ concerns in a letter to the FDA last month, and we continue our discussions with FDA and other stakeholders to identify a long-term solution,” Dr. White-Shim added.
Reasons vary for the shortage of sterile fluids such as Sodium Chloride 0.9% Injection. Media reports have pointed to increased demand in human medicine, especially during flu season, occasional recalls of contaminated product and manufacturers’ freedom to produce as much IV fluid as they see fit.
The FDA will allow the temporary distribution of Hartmann’s IV solution, a product made by Sypharma Pty Ltd. of Australia, AVMA reported. Veterinarians may contact Sypharma directly at email@example.com.
Among the largest U.S. manufacturers of sterile fluids are Baxter Healthcare Corp., Hospira Inc. and B. Braun Medical.
Baxter, based in Deerfield, Ill., produces more than 1 million units of sterile solutions each day. A fact sheet on the company website calls the manufacturing steps “complex and time-intensive.”
“Baxter is carefully managing inventory through an allocation and fulfillment process in order to expedite product for urgent need,” the company noted.