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An Analytical Analysis of Vascepa®

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anonymous

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An Analytical Analysis of Vascepa® (Icosapent Ethyl) Fatty Acid Composition with Comparison to Advertised Ingredient Claims and Fatty Acid Profiles of Lovaza® and Nature’s Bounty® Fish Oil.

Introduction: FDA-approved Vascepa is prescribed to patients with hypertriglyceridemia to reduce high triglyceride levels and cardiovascular risk. Amarin Corporation, PLC is an Irish-American biopharmaceutical company founded in 1993 and claims the following through advertising, sponsored published articles, SEC filings, investor slide presentations, and patient and physician-focused website pages, that Vascepa is: [published language excerpts] “Pure EPA,” “EPA Only,” “pure EPA only,” is “EPA only/DHA-free,” “contains no DHA,” “doesn’t contain DHA Omega-3,” an ingredient Amarin claims to have adverse health consequences, “removes LDL-raising DHA, saturated fats, toxins, and other impurities leaving only a purified ingredient,” and “excludes saturated fats, omega-6s and other components in fish oil,” with similarly worded claims in marketing and communications to the SEC, investors, and the public since circa 2012.

Purpose: To compare Amarin’s advertised Vascepa EPA-only and excluded ingredient claims of “no” DHA (docosahexaenoic acid), saturated fatty acids, omega-6 fatty acids, other fatty acids including omega-3 fatty acids other than EPA (eicosapentaenoic acid), and no fish oil components, to analytical testing results. The fatty acid composition of Lovaza (GlaxoSmithKline, Norway), a commonly prescribed FDA-approved triglyceride-lowering drug, and Nature’s Bounty Fish Oil (Bohemia, NY), an over-the-counter fish oil product are presented for comparison.

Materials and Methods: Nine (9) bottles of 1-gram/120-capsules Vascepa [V] (icosapent ethyl), sourced from multiple pharmacies, through different pharmaceutical drug distributors, with unique manufacturing lot numbers, and expiration date 08/2021 to 09/2023; one (1) bottle of 1-gram/120-capsules Lovaza [L] (omega 3-acid ethyl esters), expiration date 04/2021; and one (1) bottle of 1.2-gram/90-capsules Nature’s Bounty Fish Oil [NB] (as ethyl esters), expiration date 04/2022 were tested between 09/2018 and 05/2020 using gas-liquid chromatography (GLC) and FAME AOCS CE1i-07 method to determine fatty acid composition and percent per gram (%/g).

Results: EPA (C20:5n-3) is present in all Vascepa [V], Lovaza [L], and Nature’s Bounty Fish Oil [NB] samples. Vascepa contains the following: DHA (C22:6n-3), present in [V/L/NB]; eleven (11) saturated fatty acids including, C6:0 present in [V/L/NB], C8:0 present in [V/L], C10:0 present in [V/L], C12:0 present in [V/L/NB], C14:0 present in [V/L/NB], C15:0 present in [V/L/NB], C16:0 present in [V/L/NB], C18:0 present in [V/L/NB], C20:0 present in [V/L/NB], C22:0 present in [V/L/NB], and C24:0 present in [V/L/NB]; eight (8) omega-6 fatty acids including, C18:2n-6 present in [V/L/NB], C18:3n- 6 present in [V/L/NB], C20:2n-6 present in [V/L/NB], C20:3n-6 present in [V/L/NB], C20:4n-6 present in [V/L/NB], C22:2n- 6 present in [V/L/NB], C22:4n-6 present in [V/L/NB], and C22:5n-6 present in [V/L/NB]; five (5) omega-3 fatty acids other than EPA including, C18:3n-3 present in [V/L/NB], C18:4n-3 present in [V/L/NB], C20:3n-3 present in [V/L/NB], C20:4n- 3 present in [V/L/NB], and C22:5n-3 present in [V/L/NB]; and five (5) monounsaturated fatty acids including, C16:1 present in [V/L/NB], C18:1 present in [V/L/NB], C20:1 present in [V/L/NB], C22:1 present in [V/L/NB], and C24:1 present in [V/L/NB]. Average fatty acid percent per gram (%/g) for Vascepa: EPA 97.38%/g; DHA 0.31%/g; saturated fatty acids 0.89%/g; omega-6 fatty acids 0.45%/g; other fatty acids 0.90%/g; Total fatty acids other than EPA, 2.54%/g. Comparing fatty acid composition similarities of Vascepa, Lovaza, and Nature’s Bounty Fish Oil, Vascepa and Lovaza have thirty-one (31) of the same fatty acids in their drug product compositions with Vascepa and Nature’s Bounty Fish Oil having twenty-nine (29) fatty acids in common.

Conclusion: Amarin Corporation claims through multiple sources, that the FDA-approved drug Vascepa is pure EPA, and does not contain DHA, saturated fatty acids, omega-6 fatty acids, omega-3 fatty acids other than EPA, other fatty acids, or components in fish oil. When comparing the fatty acid profiles of the three products analyzed, Vascepa and Lovaza contain thirty-one (31) of the same fatty acids, differing only in the percent per gram (%/g) of each fatty acid, with Vascepa containing twenty-nine (29) fatty acids found in Nature’s Bounty Fish Oil. Results of this study demonstrate that in addition to EPA, Vascepa contains DHA, saturated fatty acids, omega-6 fatty acids, omega-3 fatty acids other than EPA, monounsaturated fatty acids, and fatty acids found in fish oil.

Keywords: vascepa, icosapent ethyl, icosapent, vascepa vs lovaza, vascepa vs fish oil, vascepa ingredients.
 












FDA was provided data in 2020 regarding Amarin's false advertising claims regarding what ingredients are not supposed to be contained in Vascepa, but are. To date, FDA has not addressed this issue.
 






















































Help publish this research data to other sites as Amarin is clearly fraudulent in their stock holders and SEC presentations and actual ingredients in their product VASCEPA. More data is forthcoming regarding VASCEPA impurities.
 


















My non-governmental, privately funded analytical laboratory, analyzes FDA approved drugs ingredients (API and contaminants) to determine chemical composition and potency. We report API (active pharmaceutical ingredients) and contaminant inconsistencies to FDA. We report pharmaceutical company fraudulent advertisement claims, and misrepresentative statements to SEC and FDA.

UPDATE: Regarding AMARIN's VASCEPA product, we have been unsuccessful, with no response, nor communication from FDA or AMARIN, to address analytical testing inconsistencies regarding ingredients/contaminants in the VACEPA product [see previously posted abstract of chemical composition of VASCEPA].

Our current focus is on inconsistent API potency of the most frequently prescribed heart medications and evaluating FDA approved API potencies and impurities by manufacturer/U.S./generic/.
 












anonymous said:
Ha ha! I am guessing it made the study sound more impressive, although it is quite redundant.
Click to expand...
Analytical chemistry studies and uses instruments and methods to separate, identify, and quantify matter. In practice, separation, identification or quantification may constitute the entire analysis or be combined with another method. Separation isolates analytes. Qualitative analysis identifies analytes, while quantitative analysis determines the numerical amount or concentration.
 






Analytical chemistry studies and uses instruments and methods to separate, identify, and quantify matter. In practice, separation, identification or quantification may constitute the entire analysis or be combined with another method. Separation isolates analytes. Qualitative analysis identifies analytes, while quantitative analysis determines the numerical amount or concentration.
 












anonymous said:
Analytical chemistry studies and uses instruments and methods to separate, identify, and quantify matter. In practice, separation, identification or quantification may constitute the entire analysis or be combined with another method. Separation isolates analytes. Qualitative analysis identifies analytes, while quantitative analysis determines the numerical amount or concentration.
Click to expand...
FDA has received multiple data regarding the "non-reported ingredients in VASCEPA that multiple analyses demonstrate are present, at levels significantly above reportable limits," that must be reported by AMARIN as contamination, but have not been reported to date, with FDA doing nothing regarding the data for two years. Most likely, FDA is not acting, not because there is an issue with contamination in VASCEPA, but because no patient has suffered adverse reactions outside the WARNINGS. AMARIN is required to not release products, and report to FDA any ingredient(s) in VASCEPA, based on their testing, above FDA limits, as part of quality control, that FDA did not approve to be in VASCEPA during the approval process. FDA is merely a mortuary department, not a prevention department as people think, but only responds if there is an outbreak or major health issue reported. VASCEPA contains "small fish contaminates," thirty-one of them present in VASCEPA, which should be an issue for FDA, and even though FDA has all the data of VASCEPA contamination, which is in direct conflict to the ingredients approved by FDA for VASCEPA, why FDA does not act accordingly remains of question.

Conclusion: Amarin Corporation claims through multiple sources, that the FDA-approved drug Vascepa is pure EPA, and does not contain DHA, saturated fatty acids, omega-6 fatty acids, omega-3 fatty acids other than EPA, other fatty acids, or components in fish oil. When comparing the fatty acid profiles of the three products analyzed, Vascepa and Lovaza contain thirty-one (31) of the same fatty acids, differing only in the percent per gram (%/g) of each fatty acid, with Vascepa containing twenty-nine (29) fatty acids found in Nature’s Bounty Fish Oil. Results of this study demonstrate that in addition to EPA, Vascepa contains DHA, saturated fatty acids, omega-6 fatty acids, omega-3 fatty acids other than EPA, monounsaturated fatty acids, and fatty acids found in fish oil. As such, VASCEPA ingredients are the same as a generic OTC fish oil, only differing in fatty acid concentrations.
 






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