The U.S. Food and Drug Administration said Jan. 28 it is working with the three manufacturers of intravenous saline solutions to address a shortage caused by a spike in demand.
Fresenius Medical Care North America announced in September that there is a temporary shortage of its 1-liter normal saline product. The Fresenius shortage is the result of an issue with customs affecting their production facility in Guadalajara, Mexico, which normally handles the increased demand for the product, Fresenius said in a notice to dialysis providers.
The National Renal Administrators Association sent a letter to the U.S. Food and Drug Administration in September, encouraging them to help make sure the matter is resolved safely and expeditiously. The National Renal Administrators Association said at the time that the FDA had responded and stated their belief that the shortage issue had been resolved. The NRAA said it is encouraging members to continue to look for alternative sources of saline while the resolution process is taking place.
“We’ve not heard of anyone on the edge,” Rich Meade, a spokesman for the National Renal Administrators Association, told the Washington Post.
Since January, the FDA has received notices from "dozens of hospitals" each week about low supplies of IV saline, Valerie Jensen, associate director of the drug shortages program at the U.S. Food and Drug Administration told the Post.
A spike in flu cases has increased demand for the product.