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Re: johnking29 post# 220413

Tuesday, 10/22/2019 6:04:26 AM

Tuesday, October 22, 2019 6:04:26 AM

Post# of 429503
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.
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