From Our 2013 Archives
U.S. Imports Scarce Nutrition Drugs for Sick Babies
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WEDNESDAY, May 29 (HealthDay News) -- Seeking to ease a shortage that is threatening the health of preemie babies, the U.S. Food and Drug Administration announced Wednesday it was importing certain injectable nutrition drugs.
The products in short supply include injectable drugs used in intravenous feeding solutions, which the FDA says are currently in "critical shortage."
"Hospitals nationwide rely on [this type of feeding solution], which is primarily used to treat premature infants who are unable to eat or drink by mouth or who are experiencing other deficiencies," the agency said. "Cancer patients and those who have had gastrointestinal surgeries who are also unable to eat or drink by mouth have been affected by these shortages."
The shortages were prompted by the temporary shutdown by American Regent/Luitpold in late 2012, the agency said in a news release. A large manufacturer of these products, the company has temporarily closed while it addresses "quality issues that included particulate matter in its injectable products," the FDA said.
"Since the onset of these shortages, the FDA has been very concerned about the dwindling supply of injectable nutrition products and the effect this is having on children's hospitals treating vulnerable patients," Valerie Jensen, associate director of the drug shortages program in the FDA's Center for Drug Evaluation and Research, said in the news release. "We believe the import of these injectable nutrition drugs is going to meet current supply needs over the coming weeks."
Upon learning of American Regent/Luitpold's decision to shut down temporarily, the FDA started looking for foreign suppliers. One company, Fresenius Kabi USA, based in Illinois, is importing certain feeding solution ingredients to the United States from a plant in Norway, the FDA said.
"Other manufacturers of TPN components, including Hospira Inc., of Lake Forest, Ill., are also working to increase supplies of these critical drugs," the agency added.
These are not the first drug shortages to threaten U.S. patients in recent years. In 2011 and 2012, shortages of certain cancer medications led to emergency action by the Obama Administration and the FDA.
-- E.J. Mundell
SOURCE: U.S. Food and Drug Administration, news release, May 29, 2013
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