FDA approves Clinolipid for parenteral nutrition

The FDA has approved lipid injectable emulsion Clinolipid for use as intravenous nutrition in adult patients, according to a press release.

The emulsion, marketed by Baxter Healthcare Corp., includes a combination of refined olive and soybean oils, and had been granted priority review status in order to address a shortage of injectable lipid emulsion products. The approval follows favorable results comparing Clinolipid with a soybean oil-based emulsion as an energy source. According to the release, the product does not improve clinical outcomes compared with other lipid emulsions.

Clinolipid is not intended for use in pediatric patients or those with egg or soybean protein hypersensitivity, or patients with hyperlipidemia. Clinicians should exercise caution in administering the emulsion to patients with liver insufficiency or pre-existing liver disease. Commonly observed side effects during the study included abnormal liver function tests, infection, nausea and vomiting, excess blood sugar and lipids, and reduced protein in the blood. Labeling for Clinolipid will include a warning against its use in preterm infants due to a risk for death following administration of intravenous lipid emulsions.

“Preventing and mitigating drug shortages is a top priority for the FDA,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “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.”