Tuesday, October 22, 2019 6:04:26 AM
I'm not Jesse or Bio, sorry, but I believe this is a non-issue. The FDA has been aware that "indiscriminate" intake of mineral oil could cause malabsorption of these vitamins for at least a few years. The primary purpose of white mineral oil is to relieve constipation and you swing down about 15-30 or more grams. That splashes through your esophagus, so subsequent food intake may get coated, and into the stomach like a shower. So, if there is food in your stomach, it might get coated as well. If you do this on and off for months, there may be some malabsorption of those vitamins. But in REDUCE-IT, you take two gelcaps that dissolve in the stomach over about 30 minutes which has very minimal to no effect on absorption. The DMC would have been aware of this possibility but they noticed no real effect in their safety reviews. In fact, the date on this article is from 4/1/19, so if their were any concerns the FDA had about mineral oil, they would have immediately scheduled an AdCom since they just received Amarin's sNDA. It's not an issue.
Recent AMRN News
- Earnings Report Shows Narrowing Losses as Amarin (AMRN) Advances Partner-Led Growth Strategy • IH Market News • 04/29/2026 02:19:17 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 04/29/2026 11:06:34 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/29/2026 11:05:15 AM
- Amarin Reports 2026 First Quarter Financial Results • GlobeNewswire Inc. • 04/29/2026 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/22/2026 09:00:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/21/2026 09:00:02 PM
- Amarin to Report First Quarter 2026 Financial Results and Host Conference Call on April 29, 2026 • GlobeNewswire Inc. • 04/15/2026 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 04/10/2026 09:01:34 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 04/10/2026 09:00:20 PM
- American College of Cardiology (ACC) Scientific Sessions 2026 Underscore the Need for Complementary Therapies Including Icosapent Ethyl (IPE) in Treatment of Elevated Triglycerides and Cardiovascular Risk Reduction • GlobeNewswire Inc. • 04/08/2026 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/02/2026 08:30:11 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 03/30/2026 09:57:06 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/27/2026 09:00:07 PM
- Amarin Highlights Guideline Recommended Role of Icosapent Ethyl in Managing Cardiovascular Risk Following Release of Updated 2026 ACC/AHA/Multisociety Dyslipidemia Guideline • GlobeNewswire Inc. • 03/18/2026 12:30:00 PM
- New REDUCE-IT Data in Patients at Extreme Cardiovascular Risk and In Vitro Research on the Mechanistic Effects of Eicosapentaenoic Acid (EPA) on Lipoprotein(a) [Lp(a)] Oxidation to be Presented at the American College of Cardiology’s (ACC) Annual Scienti • GlobeNewswire Inc. • 03/16/2026 12:15:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/02/2026 10:31:01 PM
- Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT® Post Hoc Analysis Published in the European Journal of Preventive Cardiology • GlobeNewswire Inc. • 03/02/2026 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/25/2026 12:05:26 PM
- Amarin Reports Fourth Quarter and Full Year 2025 Financial Results • GlobeNewswire Inc. • 02/25/2026 12:00:00 PM
- This American Heart Month Amarin Spotlights the Need to Prioritize Proven Widely Available Yet Underutilized Therapies in the Battle Against Cardiovascular Disease • GlobeNewswire Inc. • 02/23/2026 01:00:00 PM
