The FDA announced that injectable drugs used in total parenteral nutrition (TPN) that are in critical shortage will be imported into the United States and be available to patients this week.
The shortage is primarily due to American Regent/Luitpold’s temporary shut down at the end of 2012. The shutdown happened in order to address quality assurance issues that included particulate matter in its injectable products. The FDA has been working with the company to prioritize the most critical drugs as it restarts production.
The import will be coming from the Norway plant of Fresenius Kabi U.S.A. When the FDA looks for a foreign source to strengthen the supply in the United States, the agency evaluates the foreign drug for adequate quality and any undue risks for patients.
Other manufacturers of TPN components (eg, Hospira, Inc.) are also working to increase supplies of these critical drugs.
TPN is an intravenous food solution containing trace elements, potassium phosphate, and sodium phosphate, which have been in short supply. TPN is used to treat premature infants who are unable to eat or drink by mouth or who are experiencing other deficiencies. In addition, this shortage has affected patients with cancer and those that have had gastrointestinal surgeries who are also unable to eat or drink by mouth.
For more information call (888) INFO-FDA or visit the FDA website.