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” An important point: FDA approval does NOT automatically mean the drug is safe Approved drugs can still cause harm Some are later restricted, relabeled, or even pulled from the market That’s part of what a monitored drug system is supposed to do Peter can think of countless examples of drugs that get pulled off the market when post-market surveillance either demonstrates the efficacy is not large enough, or the side effects or unwanted off-target consequences of the drug are too great This is a reason that approval is indication specific A drug may have a reasonable risk-benefit profile in one population, but a very poor one in another One of the very popular peptides, SS-31 is a good example of this It may make sense to approve a mitochondrial targeting peptide in people with Barth syndrome (which is a severe life-limiting mitochondrial disease) based on limited evidence That does NOT mean we have enough information to make an informed risk-benefit calculation for a healthy person taking it for energy, performance, or longevity “ A risk that is acceptable when the alternative is early death, may be completely unacceptable when the expected benefit is speculative Styles:GC59 - 17 mm, Light, Doll Eye, Natural Dihexa as a nootropic: separating rat studies from human reality by… NAD+ Production https://assets.fishersci.com/TFS-Assets/CCG/product-images/F133793~p.eps-650.jpg