"On April 3, 2015, the U.S. District Court for the District of Massachusetts on behalf of the U.S. Food and Drug Administration has filed a consent decree of permanent injunction against Michael P. Ferry Inc., a dairy operation located in Westport"...
Deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature.1,2Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant's ability to eliminate infused fat from the circulation must be carefully monitored (such as triglyceride and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.
Caution should be exercised in administering Liposyn II (Intravenous Fat Emulsion) to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders or when there is danger of fat embolism. The too rapid administration of Liposyn II (intravenous fat emulsion) can cause fluid and/or fat overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity or metabolic acidosis.
Caution should be exercised when admixing Liposyn II (Intravenous Fat Emulsion).
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Because free fatty acids displace bilirubin bound to albumin, the use of lipid infusions in jaundiced or premature infants should be undertaken with caution.
During Liposyn II (intravenous fat emulsion) administration, the patient's hemogram, blood coagulation, liver function, platelet count and plasma lipid profile must be closely monitored. The lipemia must clear between daily infusions. Liposyn II (intravenous fat emulsion) should be discontinued should a significant abnormality in any one of these parameters be attributed to the infusion.
Pregnancy Category C
Animal reproduction studies have not been conducted with Liposyn II (intravenous fat emulsion) . It is also not known whether Liposyn II (intravenous fat emulsion) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Liposyn II (intravenous fat emulsion) should be given to a pregnant woman only if clearly needed.
It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Liposyn II (intravenous fat emulsion) is administered to a nursing woman.
Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with Liposyn II (intravenous fat emulsion) .
Liposyn II (intravenous fat emulsion) is supplied in single-dose containers. Partially used containers must be discarded and should not be stored or resterilized for later use. Do not administer the contents of any container in which the emulsion appears to be oiling out.
This product contains no more than 25 mcg/L of aluminum.
1. Levene M, Wigglesworth J, Desai R. Pulmonary fat accumulation after Intralipid infusion in the preterm infant.Lancet II: 815-818, (Oct. 18), 1980.
2. Dahms B, Halpin T. Pulmonary arterial lipid deposit in newborn infants receiving intravenous lipid infusion. J. Pediatrics: 97:800-805, (Nov.), 1980.
Last reviewed on RxList: 1/30/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Liposyn II Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Weight Loss Wisdom
Get tips, recipes and inspiration.