The Food and Drug Administration announced that injectable drugs that are used in total parenteral nutrition and are in critical shortage will be imported into the United States and available to patients this week.
TPN contains several drugs that have been in short supply, including trace elements, potassium phosphate and sodium phosphate. Hospitals nationwide rely on TPN, which is primarily used to treat premature infants who are unable to eat or drink by mouth or who experience other deficiencies.
Cancer patients and those who have had gastrointestinal surgeries who are unable to eat or drink by mouth also have been affected by these shortages.
“TPN component shortages have been a high priority for the agency,” Valerie Jensen, RPh, associate director of drug shortages in the FDAs Center for Drug Evaluation and Research, said in a news release. “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 childrens hospitals treating vulnerable patients.
“We believe the import of these injectable nutrition drugs is going to meet current supply needs.”
The FDA is exercising regulatory discretion for Fresenius Kabi USA, LLC, based in Lake Zurich, Ill., to import trace elements and phosphate injection from its Norway plant to allow the drugs to reach Americans in need.
The shortages largely are the result of a decision by American Regent/Luitpold, a large manufacturer of TPN products, to temporarily shut down at the end of 2012. The FDA worked with American Regent to avoid a shutdown, but the company decided it had to cease operations temporarily to address quality issues that included particulate matter in its injectable products. The FDA continues to work with the company to prioritize the most critical drugs in shortage while protecting patient health as it restarts production.
Upon learning of American Regents decision to temporarily shut down, the FDA looked for ways to increase supply and ultimately sought foreign companies that were willing and able to help the United States resolve these shortages. The agency evaluated the foreign drug to ensure it is of adequate quality and does not pose undue risks for U.S. patients.
The FDAs stated that its exercise of enforcement discretion for these TPN components is temporary, and applied to address this critical shortage. While the FDA cannot force a manufacturer to make a product, the agency will continue to provide expedited regulatory review and advice to manufacturers of TPN components and other drugs most in need.
Other manufacturers of TPN components, including Hospira Inc. of Lake Forest, Ill., also are working to increase supplies of these critical drugs, the FDA stated.
Since 2010, the FDA has used its regulatory discretion for the importation of 14 drugs. With the addition of these injectable nutrition drugs, the total will be at 17.
Read more information about TPN: www.nlm.nih.gov/medlineplus/druginfo/meds/a601166.html.