"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"...
THE ADVERSE REACTIONS OBSERVED CAN BE SEPARATED INTO TWO CLASSES:
- THOSE MORE FREQUENTLY ENCOUNTERED ARE DUE: EITHER TO CONTAMINATION OF THE INTRAVENOUS CATHETER AND RESULT IN SEPSIS, OR TO VEIN IRRITATION BY CONCURRENTLY INFUSED HYPERTONIC SOLUTIONS AND MAY RESULT IN THROMBOPHLEBITIS. THESE ADVERSE REACTIONS ARE INSEPARABLE FROM THE HYPERALIMENTATION PROCEDURE WITH OR WITHOUT INTRALIPID® 20% (A 20% I.V. FAT EMULSION).
- LESS FREQUENT REACTIONS MORE DIRECTLY RELATED TO INTRALIPID® 20% (20% i.v. fat emulsion) ARE: A) IMMEDIATE OR EARLY ADVERSE REACTIONS, EACH OF WHICH HAS BEEN REPORTED TO OCCUR IN CLINICAL TRIALS, IN AN INCIDENCE OF LESS THAN 1%; DYSPNEA, CYANOSIS, ALLERGIC REACTIONS, HYPERLIPEMIA, HYPERCOAGULABILITY, NAUSEA, VOMITING, HEADACHE, FLUSHING, INCREASE IN TEMPERATURE, SWEATING, SLEEPINESS, PAIN IN THE CHEST AND BACK, SLIGHT PRESSURE OVER THE EYES, DIZZINESS, AND IRRITATION AT THE SITE OF INFUSION, AND, RARELY, THROMBOCYTOPENIA IN NEONATES; B) DELAYED ADVERSE REACTIONS SUCH AS HEPATOMEGALY, JAUNDICE DUE TO CENTRAL LOBULAR CHOLESTASIS, SPLENOMEGALY, THROMBOCYTOPENIA, LEUKOPENIA, TRANSIENT INCREASES IN LIVER FUNCTION TESTS, AND OVERLOADING SYNDROME (FOCAL SEIZURES, FEVER, LEUKOCYTOSIS, HEPATOMEGALY. SPLENOMEGALY AND SHOCK).
THE DEPOSITION OF A BROWN PIGMENTATION IN THE RETICULOEN-DOTHELIAL SYSTEM, THE SO CALLED "INTRAVENOUS FAT PIGMENT," HAS BEEN REPORTED IN PATIENTS INFUSED WITH INTRALIPID® 20% (20% i.v. fat emulsion) . THE CAUSES AND SIGNIFICANCE OF THIS PHENOMENON ARE UNKNOWN.
Read the Intralipid 20% (20% i.v. fat emulsion) Side Effects Center for a complete guide to possible side effects
No information provided
Last reviewed on RxList: 7/30/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Intralipid 20% Information
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