For Immediate Release: Oct. 3, 2013
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FDA approves Clinolipid for intravenous nutrition
Action addresses shortages of drugs needed by patients unable to eat or drink
The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink. Clinolipid was granted a priority review to help alleviate a drug shortage.
“Preventing and mitigating drug shortages is a top priority for the FDA,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Approving submissions from manufacturers who can start new production or increase existing production of a product in short supply is one of the many effective mitigation tools that the FDA employs to address a shortage problem.”
Clinolipid is a lipid emulsion that contains a mixture of refined olive oil and refined soybean oil. The fatty acids contained in Clinolipid serve as an important source of energy in patients receiving parenteral nutrition. The omega-3: omega-6 fatty acid ratio in Clinolipid has not been shown to improve clinical outcomes compared to other lipid emulsion products.
“The FDA has been very concerned about the short supply of injectable lipid emulsion products,” said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Clinolipid will help in the effort to resolve this shortage so that patients have access to these parenteral nutrition products.”
Clinolipid is intended for adults, and like other intravenous lipid emulsions, should be used with caution in patients with preexisting liver disease or liver insufficiency. Clinolipid should not be used in patients with a known hypersensitivity to egg or soybean proteins, or in those with severe disorders of lipid metabolism (hyperlipidemia).
The safety and effectiveness of Clinolipid were evaluated in clinical efficacy and safety studies comparing Clinolipid with a soybean oil-based lipid emulsion. Clinolipid is an effective source of energy in adults. The most common side effects in patients treated with Clinolipid during clinical trials included infectious complications, nausea and vomiting, excess fat (lipids) in the blood, high blood sugar, low levels of protein in the blood and abnormal liver function tests.
Clinolipid is not indicated for use in preterm infants. The product carries a warning in its label about the risk of death in preterm infants after infusion of intravenous lipid emulsions such as Clinolipid.
Clinolipid is also not indicated for use in other pediatric patients because it is not known whether the amount of essential fatty acids found in Clinolipid is enough to meet the nutritional needs of children.
Clinolipid is marketed by Deerfield, Ill.-based Baxter Healthcare Corporation.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Editor’s Note: The FDA approval of Clinolipid is an activity that is funded under FDA’s user fee program in the Center for Drug Evaluation and Research (CDER). Some excepted FDA activities that do not rely on annual appropriations are continuing during the government shutdown.