How FDA Guidelines On The Adverse Effects Of Statins Are Very Telling

by Dr John Briffa
for The Cholesterol Truth


The Food and Drug Administration in the US is responsible for making decisions about which drugs should be licensed. It also keeps a database of information regarding the adverse effects of drugs, and occasionally revises the warnings issued with prescription medication. On the 28th of February, the FDA issued new guidelines regarding the management of individuals taking statins. You can read these guidelines here. The FDA, in its new guidelines, also draws our attention to the evidence which links statin use with impaired blood sugar control. The new guidelines warn doctors and patients alike about this. It adds, though, that: “[the] FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

Just to remind ourselves, many individuals need to take statins for several years for one to avoid having a heart attack. What this means, is that the vast majority of people who take statins will not benefit from them at all. Also, the majority of people who take statins are essentially healthy (no history of, say, heart disease or stroke). In these people, statins do not reduce overall risk of death over time. What this means is that for the great majority of people, taking statins will not extend their life by a single day. The new guidelines issued by the FDA only serve, I think, to remind us that the risk/benefit ratio of statins is not so stacked in favour of ‘benefit’ as we have been led to believe.

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