The US Food and Drug Administration (FDA) yesterday approved a new intravenous nutritional product for adults to alleviate a shortage of such drugs, the agency announced.
The product is lipid injectable emulsion, USP (Clinolipid, Baxter Healthcare), which supplies calories and essential fatty acids for patients who cannot eat or drink.
"The FDA has been very concerned about the short supply of injectable lipid emulsion products," said Donna Griebel, MD, director of the Division of Gastroenterology and Inborn Errors Products in the FDA's Center for Drug Evaluation and Research, in a news release. "[The] approval of Clinolipid will help in the effort to resolve this shortage."
The lipid emulsion contains refined olive oil and refined soybean oil. Although the fatty acids are an important source of energy, the ratio of omega-3 fatty acids to their omega-6 cousins in the new drug "has not been shown to improve clinical outcomes compared to other lipid emulsion products," according to the FDA.
Clinicians should use lipid injectable emulsion, USP, cautiously in patients with preexisting liver disease or liver insufficiency. It is not indicated for use in patients with a known hypersensitivity to egg or soybean products, or in those with hyperlipidemia.
The FDA also has not approved the new drug for preterm infants because, like other intravenous lipid emulsions, it poses the risk for death in this group. The drug also is not indicated for older pediatric patients because it isn't known whether it contains enough essential fatty acids to adequately nourish children.
The FDA found lipid injectable emulsion, USP, to be safe and effective on the basis of clinical trials that compared the new drug to a soybean-based lipid emulsion. The most common adverse events observed in the clinical trials were infectious complications, nausea and vomiting, excess fat in the blood, high blood sugar, low bloodstream levels of protein, and abnormal liver function tests.
More information about lipid injectable emulsion, USP, is available on the FDA Web site.
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Cite this: FDA Approves Clinolipid for IV Nutrition, Easing Shortage - Medscape - Oct 04, 2013.