SAFETY AND UTILITY OF I.V. FAT EMULSION FOR HUMAN INTRAVENOUS ADMINISTRATION

The initial clinical experiences of our group with a European fat emulsion called Intralipid is reported. This emulsion is composed of soy bean oil, egg lecithin and glycerol. One hundred and thirty-four bottles, containing 500 cc of a 20% fat emulsion, were administered intravenously to 110 patients afflicted with a variety of diseases, mainly cancer. The overall incidence of a febrile reaction was 13.5%, characterized by being delayed for some 2-6 hours after the end of the infusion, often accompanied by shaking chills, nausea, and vomiting. Six different production lots were tested which showed great variability, one from the other, in their reactivity. Six subjects received short term daily infusions of either 4 or 5 days duration. Hematologic and liver function studies failed to show changes during this relatively short period of consecutive infusions. Clearing studies failed to show correlation between febrile response and rapidity with which clearing of the emulsion occurred. It is concluded that Intralipid is not a safe or suitable product for routine clinical use. (Author)