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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