FDA addresses IV nutrition shortage with lipid injectable emulsion approval

Under a priority review to help alleviate a drug shortage, FDA has approved lipid injectable emulsion, USP (Clinolipid, Baxter Healthcare) 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.

FDA has expressed concerned about the short supply of injectable lipid emulsion products.

“It is understood that drug shortages tend to occur and in certain cases it is important that people continue to receive life-sustaining medications or treatments without any break in continuity of care,” Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “The approval of Clinolipid demonstrated FDA’s ongoing efforts to ensure that priority is given to these agents and they are made available to the public without significant delay.”

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.                                    

Clinolipid is meant 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. 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 are the most common side effects in patients treated with Clinolipid during clinical trials.  

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. It 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.