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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The CLINOLIPID trials had small sample sizes and patients had a variety of underlying medical conditions both between different trials and within the individual trials. Patients had gastrointestinal diseases/dysfunction or were recovering from gastrointestinal or other surgeries, trauma, burns, or were afflicted by other chronic illness. The largest trial (Study 1, 48 subjects) enrolled patients with many different underlying diagnoses. The rates of treatment emergent adverse reactions can therefore not be directly compared to rates observed in the clinical trials of other related products and may not reflect the rates observed in clinical practice.
Commonly observed adverse reactions in 261 adult patients who received CLINOLIPID were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests and occurred in 2 to 10 % of patients. In Study 1 the most common adverse reactions were infectious complications Â(urinary tract infection, septicemia, and fever of unknown origin), treatment emergent abnormalities on liver/gallbladder ultrasound and abnormalities of serum chemistries, principally, hepatic function tests. Adverse reactions in Study 2 were similar.
Adverse reactions reported in long-term use with other intravenous lipid emulsions include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, abnormalities in liver function tests, brown pigmentation of the liver and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
The following adverse reactions have been identified during use of CLINOLIPID, and listed by MedDRA System Organ Class, then by Preferred Term in order of severity. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Diarrhea
Skin and Subcutaneous Tissue Disorders: Pruritus
Immune System Disorders: Hypersensitivity with the manifestations of rash and dyspnea
Investigations: International normalized ratio (INR) decreased in anticoagulated patients [see DRUG INTERACTIONS]
Read the Clinolipid (lipid injectable emulsion for intravenous use) Side Effects Center for a complete guide to possible side effects
No drug interaction studies have been performed with CLINOLIPID.
Olive and soybean oils have a natural content of Vitamin K1 that may counteract the anticoagulant activity of coumarin derivatives, including warfarin.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/1/2016
Additional Clinolipid 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.
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